Trial Outcomes & Findings for Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System (NCT NCT05058456)
NCT ID: NCT05058456
Last Updated: 2026-08-03
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)
COMPLETED
NA
35 participants
30 days
2026-08-03
Participant Flow
Participant milestones
| Measure |
Single-arm
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
Reached 30 Day Post Procedure Follow Up
|
33
|
|
Overall Study
Reached 6 Month Post Procedure Follow Up
|
31
|
|
Overall Study
Reached 12 Month Post Procedure Follow Up
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Single-arm
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System
Baseline characteristics by cohort
| Measure |
Single-arm
n=35 Participants
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Age, Continuous
|
76.3 years
STANDARD_DEVIATION 8.5 • n=20 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=20 Participants
|
|
Region of Enrollment
New Zealand
|
22 Participants
n=20 Participants
|
|
Region of Enrollment
Australia
|
13 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: This feasibility study was analyzed descriptively. While the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study, no statistical significance testing was performed for the standalone Mini-S study results presented in this record. Therefore, no statistical analysis results are available for reporting in the Statistical Analysis sections of the outcome measures.
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)
Outcome measures
| Measure |
Single Arm
n=35 Participants
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Primary Safety: Major Adverse Events (MAE)
|
1 Participants
|
PRIMARY outcome
Timeframe: Peri-ProceduralPopulation: This feasibility study was analyzed descriptively. While the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study, no statistical significance testing was performed for the standalone Mini-S study results presented in this record. Therefore, no statistical analysis results are available for reporting in the Statistical Analysis sections of the outcome measures.
Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core lab
Outcome measures
| Measure |
Single Arm
n=35 Participants
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Primary Performance: Technical Success
|
35 Participants
|
SECONDARY outcome
Timeframe: Peri-ProceduralPopulation: This feasibility study was analyzed descriptively. While the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study, no statistical significance testing was performed for the standalone Mini-S study results presented in this record. Therefore, no statistical analysis results are available for reporting in the Statistical Analysis sections of the outcome measures.
Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory.
Outcome measures
| Measure |
Single Arm
n=35 Participants
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Serious Angiographic Complications
|
0 Participants
|
SECONDARY outcome
Timeframe: Peri-ProceduralPopulation: This feasibility study was analyzed descriptively. While the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study, no statistical significance testing was performed for the standalone Mini-S study results presented in this record. Therefore, no statistical analysis results are available for reporting in the Statistical Analysis sections of the outcome measures.
Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation).
Outcome measures
| Measure |
Single Arm
n=35 Participants
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
IVL Technical Success (Post- Dilatation)
|
30 Participants
|
SECONDARY outcome
Timeframe: Peri-ProceduralPopulation: This feasibility study was analyzed descriptively. While the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study, no statistical significance testing was performed for the standalone Mini-S study results presented in this record. Therefore, no statistical analysis results are available for reporting in the Statistical Analysis sections of the outcome measures.
Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter
Outcome measures
| Measure |
Single Arm
n=44 Javelin Catheters
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
IVL Device Success
|
41 Javelin Catheters
|
SECONDARY outcome
Timeframe: Peri-ProceduralPopulation: This feasibility study was analyzed descriptively. While the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study, no statistical significance testing was performed for the standalone Mini-S study results presented in this record. Therefore, no statistical analysis results are available for reporting in the Statistical Analysis sections of the outcome measures.
Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory
Outcome measures
| Measure |
Single Arm
n=35 Participants
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Technical Success (Final)
|
25 Participants
|
SECONDARY outcome
Timeframe: 6 Months Post-ProcedurePopulation: This feasibility study was analyzed descriptively. While the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study, no statistical significance testing was performed for the standalone Mini-S study results presented in this record. Therefore, no statistical analysis results are available for reporting in the Statistical Analysis sections of the outcome measures.
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 |
Single Arm
n=33 Participants
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Major Adverse Events (MAEs) at 6-months Post Procedure
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 Months Post-ProcedurePopulation: This feasibility study was analyzed descriptively. While the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study, no statistical significance testing was performed for the standalone Mini-S study results presented in this record. Therefore, no statistical analysis results are available for reporting in the Statistical Analysis sections of the outcome measures.
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 |
Single Arm
n=33 Participants
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
MAEs at 12-months Post Procedure
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 Months post-procedurePopulation: The overall number of units analyzed is defined as the overall number of target lesions treated in the 33 subjects analyzed. This feasibility study was analyzed descriptively. While the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study, no statistical significance testing was performed for the standalone Mini-S study results presented in this record. Therefore, no statistical ana
Primary patency for Above-the-Knee (ATK) lesions is defined as freedom from ≥50% restenosis as determined by DUS and freedom from CD-TLR at 12 months post-procedure. Primary patency for Below-the-Knee (BTK) lesions is defined as freedom from total occlusion (100% diameter stenosis by DUS) in all target lesions within a flow pathway and freedom from CD-TLR at 12 months post-procedure.
Outcome measures
| Measure |
Single Arm
n=32 Target Lesions
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Primary Patency at 12 Months
Primary Patency (Above the Knee)
|
18 Target Lesions
|
|
Primary Patency at 12 Months
Primary Patency (Below the Knee)
|
6 Target Lesions
|
Adverse Events
Mini S Peripheral IVL Catheter
Serious adverse events
| Measure |
Mini S Peripheral IVL Catheter
n=35 participants at risk
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Cardiac disorders
Myocardial Infarction
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Cardiac disorders
Supraventricular Tachycardia
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Cardiac disorders
Ventricular Tachycardia
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Eye disorders
Cataract
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
General disorders
Chest pain
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Infections and infestations
Cellulitis
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Infections and infestations
COVID-19
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Infections and infestations
Soft Tissue Infection
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Injury, poisoning and procedural complications
Vascular procedure complications
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Surgical and medical procedures
Hip Arthroplasty
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Surgical and medical procedures
Palliative Care
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Surgical and medical procedures
Toe amputation
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Surgical and medical procedures
Tooth Extraction
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Vascular disorders
Orthostatic hypotension
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
8.6%
3/35 • Number of events 3 • From enrollment until end of follow-up, 12 months post procedure
|
|
Vascular disorders
Peripheral artery restenosis
|
8.6%
3/35 • Number of events 3 • From enrollment until end of follow-up, 12 months post procedure
|
|
Vascular disorders
Peripheral Vascular Disorder
|
2.9%
1/35 • Number of events 1 • From enrollment until end of follow-up, 12 months post procedure
|
Other adverse events
| Measure |
Mini S Peripheral IVL Catheter
n=35 participants at risk
Shockwave Medical Mini S Peripheral IVL Catheter: The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
|
|---|---|
|
Infections and infestations
COVID-19
|
11.4%
4/35 • Number of events 4 • From enrollment until end of follow-up, 12 months post procedure
|
|
Infections and infestations
Pneumonia
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Injury, poisoning and procedural complications
Limb Injury
|
5.7%
2/35 • Number of events 3 • From enrollment until end of follow-up, 12 months post procedure
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
28.6%
10/35 • Number of events 10 • From enrollment until end of follow-up, 12 months post procedure
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Nervous system disorders
Syncope
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Renal and urinary disorders
Acute kidney injury
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Surgical and medical procedures
Toe amputation
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Vascular disorders
Intermittent Claudication
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Cardiac disorders
Coronary artery disease
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
General disorders
Peripheral swelling
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
5.7%
2/35 • Number of events 2 • From enrollment until end of follow-up, 12 months post procedure
|
|
Vascular disorders
Peripheral artery restenosis
|
20.0%
7/35 • Number of events 10 • From enrollment until end of follow-up, 12 months post procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place