Trial Outcomes & Findings for Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2) (NCT NCT02369848)
NCT ID: NCT02369848
Last Updated: 2018-04-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
12 months post-procedure
Results posted on
2018-04-18
Participant Flow
Study recruitment and enrollment took place at eight clinical sites in Austria, Germany and New Zealand between August 2015 and December 2015. A total of 60 subjects with calcified, stenotic peripheral arteries were enrolled and treated with the device.
Participant milestones
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
30 Day Primary Safety Endpoint
|
58
|
|
Overall Study
12 Month Primary Endpoint
|
30
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)
Baseline characteristics by cohort
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=60 participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
New Zealand
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
Austria
|
30 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
24 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 months post-procedurePopulation: Data reflects number for participants who have an evaluable (diagnostic) scheduled or unscheduled duplex ultrasound based on reporting windows and slotting rules in the Statistical Plan. Thirty out of 43 participants achieved target lesion patency.
Outcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=43 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Effectiveness Endpoint Defined as Number of Participants withTarget Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis
|
30 Participants
|
PRIMARY outcome
Timeframe: Within 30 days following procedureNeed for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion or distal to the treated lesion after the index procedure and results in extended hospitalization or noted angiographically, and requiring mechanical or pharmacologic means to improve flow and results in extended hospitalization. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.
Outcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=59 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Safety Endpoint Defined as Composite of New-onset Major Adverse Events (MAEs)
|
58 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=57 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Safety Measured by Number of Participants With Freedom From Major Adverse Events (MAEs)
|
56 Participants
|
SECONDARY outcome
Timeframe: Day of ProcedurePopulation: Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted.
1. The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of \<50% (with or without adjunctive Percutaneous Transluminal Angioplasty (PTA) therapy) as assessed by quantitative angiography via core lab evaluation. 2. The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of \<50% (without adjunctive PTA therapy) as assessed by quantitative angiography via core lab evaluation.
Outcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=60 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Secondary Endpoint of Acute Procedural Success Achieved in Number of Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=43 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Secondary Patency Measured by Number of Participants With Target Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis.
|
30 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=42 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Secondary Patency Measured by Number of Participants With Target Lesion Patency (Without Adjunctive PTA) by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis.
|
30 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).
Outcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=55 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Clinical Success - Improvement of Ankle-Brachial Index (ABI) of the Target Limb.
|
0.3 Percent change in ABI from baseline
Interval 0.2 to 0.3
|
SECONDARY outcome
Timeframe: 12 monthsThe ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).
Outcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=53 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Clinical Success - Improvement of Ankle-Brachial (ABI) of the Target Limb.
|
0.2 Percent change in ABI from baseline
Interval 0.2 to 0.3
|
SECONDARY outcome
Timeframe: 6 monthsChange in Rutherford Clinical Category at from Baseline to 6 months. There are seven stages to consider: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Outcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=58 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Clinical Success
|
-2.0 change in Rutherford score from baseline
Interval -2.31 to -1.76
|
SECONDARY outcome
Timeframe: 12 monthsChange in Rutherford Clinical Category from Baseline to12 months. There are seven stages to condsider: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Outcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=56 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Clinical Success
|
-2.1 change in Rutherford score from baseline
Interval -2.33 to -1.78
|
SECONDARY outcome
Timeframe: 30 daysChange in Rutherford Clinical Category from Baseline to 30 days There are seven stages to condsider: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Outcome measures
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=58 Participants
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Clinical Success
|
-2.3 change in Rutherford score from baseline
Interval -2.52 to -2.1
|
Adverse Events
Shockwave Medical Inc. Peripheral Lithoplasty
Serious events: 31 serious events
Other events: 48 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=60 participants at risk
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia Of Malignant Disease
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Cardiac disorders
Angina Pectoris
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Cardiac disorders
Atrioventricular Block
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Cardiac disorders
Cardiac Failure
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Cardiac disorders
Coronary Artery Disease
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Cardiac disorders
Heart Valve Incompetence
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Gastrointestinal disorders
Ascites
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
3.3%
2/60 • Number of events 2 • through 30 days, 6 months, 12 months
|
|
Infections and infestations
Cellulitis
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Infections and infestations
Gastrointestinal Infection
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Accident
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Peripheral Artery Restenosis
|
10.0%
6/60 • Number of events 6 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
3.3%
2/60 • Number of events 2 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Of Colon
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
3.3%
2/60 • Number of events 2 • through 30 days, 6 months, 12 months
|
|
Nervous system disorders
Cerebral Infarction
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Nervous system disorders
Convulsion
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Renal and urinary disorders
Renal Failure
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Surgical and medical procedures
Angioplasty
|
5.0%
3/60 • Number of events 3 • through 30 days, 6 months, 12 months
|
|
Surgical and medical procedures
Coronary Arterial Stent Insertion
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Surgical and medical procedures
Stent Placement
|
5.0%
3/60 • Number of events 3 • through 30 days, 6 months, 12 months
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Vascular disorders
Hypertensive Crisis
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Vascular disorders
Ischaemia
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
5.0%
3/60 • Number of events 3 • through 30 days, 6 months, 12 months
|
|
Vascular disorders
Peripheral Artery Stenosis
|
10.0%
6/60 • Number of events 6 • through 30 days, 6 months, 12 months
|
Other adverse events
| Measure |
Shockwave Medical Inc. Peripheral Lithoplasty
n=60 participants at risk
The Shockwave Medical Inc. Peripheral Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter system designed to be delivered through the peripheral arterial system of the lower extremities to the site of a calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy emitters and generator.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Cardiac disorders
Tachycardia
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Eye disorders
Visual impairment
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Gastrointestinal disorders
Faecal Incontinence
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
3.3%
2/60 • Number of events 2 • through 30 days, 6 months, 12 months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
General disorders
Gait Disturbance
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
General disorders
Oedema Peripheral
|
6.7%
4/60 • Number of events 4 • through 30 days, 6 months, 12 months
|
|
General disorders
Vessel Puncture Site Haematoma
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Infections and infestations
Eczema Infected
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Infections and infestations
Otitis Externa
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Infections and infestations
Skin Bacterial Infection
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Infections and infestations
Tinea Pedis
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
3.3%
2/60 • Number of events 2 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Laceration
|
3.3%
2/60 • Number of events 2 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Limb Injury
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Peripheral Artery Restenosis
|
25.0%
15/60 • Number of events 15 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Scratch
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
5.0%
3/60 • Number of events 3 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Wound
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.3%
2/60 • Number of events 2 • through 30 days, 6 months, 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Psychiatric disorders
Delirium
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
2/60 • Number of events 2 • through 30 days, 6 months, 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Vascular disorders
Bleeding Varicose Vein
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
|
Vascular disorders
Peripheral Embolism
|
1.7%
1/60 • Number of events 1 • through 30 days, 6 months, 12 months
|
Additional Information
Gheda Sahyun, Director of Clinical Affairs
Shockwave Medical, Inc.
Phone: 510-624-9073
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place