Trial Outcomes & Findings for FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter (NCT NCT05858905)
NCT ID: NCT05858905
Last Updated: 2026-07-14
Results Overview
Major Adverse Events (MAE) at 30 days defined as a composite of: * Cardiovascular death * Clinically-Driven Target Lesion Revascularization (CD-TLR) * Unplanned Target Limb Major Amputation (Above the Ankle)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
30 Days
Results posted on
2026-07-14
Participant Flow
Participant milestones
| Measure |
JAVELIN Study Catheter
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
30 Days Post-Procedure
|
75
|
|
Overall Study
6 Month Post-Procedure
|
69
|
|
Overall Study
12 Months Post-Procedure
|
64
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
JAVELIN Study Catheter
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter
Baseline characteristics by cohort
| Measure |
JAVELIN Study Catheter
n=75 Participants
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 8.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 30 DaysMajor Adverse Events (MAE) at 30 days defined as a composite of: * Cardiovascular death * Clinically-Driven Target Lesion Revascularization (CD-TLR) * Unplanned Target Limb Major Amputation (Above the Ankle)
Outcome measures
| Measure |
JAVELIN Study Catheter
n=75 Participants
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days
|
1 Participants
|
PRIMARY outcome
Timeframe: Peri-Procedural, immediately after all therapy of the target lesion was completed.Population: Analysis was performed at the lesion level, where 75 subjects had 84 target lesions with evaluable data.
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab.
Outcome measures
| Measure |
JAVELIN Study Catheter
n=84 Lesions
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Primary Effectiveness Endpoint - Technical Success
|
83 Lesions
|
SECONDARY outcome
Timeframe: Peri-ProceduralDefined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory
Outcome measures
| Measure |
JAVELIN Study Catheter
n=84 Lesions
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Serious Angiographic Complications
|
1 Lesions
|
SECONDARY outcome
Timeframe: Peri-ProceduralDefined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, as assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation).
Outcome measures
| Measure |
JAVELIN Study Catheter
n=79 lesions
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
IVL Technical Success (Post- Dilatation)
|
73 lesions
|
SECONDARY outcome
Timeframe: Peri-ProceduralDefined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter.
Outcome measures
| Measure |
JAVELIN Study Catheter
n=96 Javelin Devices
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
IVL Device Success
|
89 Javelin Devices
|
SECONDARY outcome
Timeframe: Peri-ProceduralDefined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory
Outcome measures
| Measure |
JAVELIN Study Catheter
n=84 Lesions
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Technical Success (Final)
|
72 Lesions
|
SECONDARY outcome
Timeframe: 6 Months Post-ProcedurePopulation: MAEs through 6 Months were assessed for all enrolled subjects, except for those who withdrew or were lost to follow. Subjects who have died within the 6 Month follow-up period were included as Cardiovascular Death adjudications falls under the MAE endpoint.
Major Adverse Events (MAEs) at 6 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle)
Outcome measures
| Measure |
JAVELIN Study Catheter
n=71 Participants
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
MAEs at 6-months Post Procedure
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 Months Post-ProcedurePopulation: MAEs through 12 Months were assessed for all enrolled subjects, except for those who withdrew or were lost to follow. Subjects who have died within the 12 Month follow-up period were included as Cardiovascular Death adjudications falls under the MAE endpoint.
Major Adverse Events (MAEs) at 12 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle)
Outcome measures
| Measure |
JAVELIN Study Catheter
n=69 Participants
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
MAEs at 12-months Post Procedure
|
13 Participants
|
SECONDARY outcome
Timeframe: 12-Months Post ProcedurePopulation: 53 participants had 62 target lesions with available DUS data
* Above the knee lesions: freedom from ≥50% restenosis as determined by Duplex Ultrasound (DUS) and freedom from Clinically-Driven Target Lesion Revascularization (CD-TLR) * Below the knee lesions: freedom from both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a CD-TLR
Outcome measures
| Measure |
JAVELIN Study Catheter
n=62 Target Lesions
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Primary Patency at 12-Months
Primary Patency (Above the Knee)
|
22 Target Lesions
|
|
Primary Patency at 12-Months
Primary Patency (Below the Knee)
|
18 Target Lesions
|
Adverse Events
JAVELIN Study Catheter
Serious events: 32 serious events
Other events: 46 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
JAVELIN Study Catheter
n=75 participants at risk
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Infections and infestations
Localised Infection
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Infections and infestations
Osteomyelitis
|
5.3%
4/75 • Number of events 4 • 12 Months Post Procedure
|
|
Infections and infestations
Osteomyelitis chronic
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Infections and infestations
Pneumonia
|
2.7%
2/75 • Number of events 2 • 12 Months Post Procedure
|
|
Infections and infestations
Sepsis
|
2.7%
2/75 • Number of events 3 • 12 Months Post Procedure
|
|
Infections and infestations
Septic Shock
|
2.7%
2/75 • Number of events 2 • 12 Months Post Procedure
|
|
Infections and infestations
Urinary Tract Infection
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
2.7%
2/75 • Number of events 2 • 12 Months Post Procedure
|
|
Injury, poisoning and procedural complications
Wound Complication
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.7%
2/75 • Number of events 3 • 12 Months Post Procedure
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Musculoskeletal and connective tissue disorders
Tendon Injury
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Nervous system disorders
Bell's Palsy
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Nervous system disorders
Encephalopathy
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Nervous system disorders
Metabolic Encephalopathy
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Nervous system disorders
Transient Ischaemic attack
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Psychiatric disorders
Delirium
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.7%
2/75 • Number of events 2 • 12 Months Post Procedure
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.7%
2/75 • Number of events 2 • 12 Months Post Procedure
|
|
Surgical and medical procedures
Amputation
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Surgical and medical procedures
Debridement
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Surgical and medical procedures
Foot amputation
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Surgical and medical procedures
Toe Amputation
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Surgical and medical procedures
Venous Arterialisation
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Vascular disorders
Cerebral Haemorrhage
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Vascular disorders
Ischaemic Stroke
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Vascular disorders
Peripheral Artery Restenosis
|
10.7%
8/75 • Number of events 9 • 12 Months Post Procedure
|
|
Vascular disorders
Peripheral Ischaemia
|
1.3%
1/75 • Number of events 2 • 12 Months Post Procedure
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
4.0%
3/75 • Number of events 3 • 12 Months Post Procedure
|
|
Vascular disorders
Rectal Haemorrhage
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Vascular disorders
Vascular Occlusion
|
2.7%
2/75 • Number of events 2 • 12 Months Post Procedure
|
|
Vascular disorders
Vascular Stent Stenosis
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Cardiac disorders
Acute myocardial infarction
|
2.7%
2/75 • Number of events 2 • 12 Months Post Procedure
|
|
Cardiac disorders
Angina Unstable
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Cardiac disorders
Atrial Fibrillation
|
2.7%
2/75 • Number of events 3 • 12 Months Post Procedure
|
|
Cardiac disorders
Cardiac Failure
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Cardiac disorders
Myocardial Infarction
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Cardiac disorders
Palpitations
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Cardiac disorders
Syncope
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
1/75 • Number of events 2 • 12 Months Post Procedure
|
|
Gastrointestinal disorders
Haematochezia
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Gastrointestinal disorders
Medical Device Site Thrombosis
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Gastrointestinal disorders
Pyrexia
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Gastrointestinal disorders
Volvus
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
General disorders
Asthenia
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
General disorders
Chest pain
|
4.0%
3/75 • Number of events 3 • 12 Months Post Procedure
|
|
General disorders
Systemic inflammatory response syndrome
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Infections and infestations
COVID-19
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Infections and infestations
Clostridium difficile colitis
|
1.3%
1/75 • Number of events 1 • 12 Months Post Procedure
|
|
Infections and infestations
Gangrene
|
1.3%
1/75 • Number of events 2 • 12 Months Post Procedure
|
Other adverse events
| Measure |
JAVELIN Study Catheter
n=75 participants at risk
The JAVELIN catheter will be used to treat subjects with moderate to severely calcified peripheral artery disease (PAD) with target lesion located in a native, de novo superficial femoral, popliteal or infrapopliteal artery.
Intravascular Lithotripsy: The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
4/75 • Number of events 4 • 12 Months Post Procedure
|
|
Surgical and medical procedures
Hospice Care
|
5.3%
4/75 • Number of events 4 • 12 Months Post Procedure
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
13.3%
10/75 • Number of events 10 • 12 Months Post Procedure
|
|
Vascular disorders
Peripheral Artery Restenosis
|
12.0%
9/75 • Number of events 12 • 12 Months Post Procedure
|
|
Injury, poisoning and procedural complications
Vasculal Procedure Complication
|
25.3%
19/75 • Number of events 21 • 12 Months Post Procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place