Trial Outcomes & Findings for Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System (NCT NCT05058456)

NCT ID: NCT05058456

Last Updated: 2025-06-08

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: 35 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-06-08

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 30 Days Post-Procedure	34
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	35

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	1
Overall Study End of Study data not yet due for release	34

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=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment New Zealand	22 participants n=5 Participants
Region of Enrollment Australia	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

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) Major Adverse Events	1 participants
Primary Safety: Major Adverse Events (MAE) Cardiovascular Death	1 participants
Primary Safety: Major Adverse Events (MAE) Clinically-Driven Target Lesion Revascularization (CD-TLR)	0 participants
Primary Safety: Major Adverse Events (MAE) Unplanned Target Limb Major Amputation (Above the Ankle)	0 participants

PRIMARY outcome

Timeframe: Peri-Procedural

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 Technical Success	35 lesions
Primary Performance: Technical Success Freedom from Any Serious Flow-Limiting Dissection (D-F)	35 lesions
Primary Performance: Technical Success Residual Stenosis of less than or equal to 50%	35 lesions

SECONDARY outcome

Timeframe: Peri-Procedural

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 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.

Serious Angiographic Complications

0 Lesions

SECONDARY outcome

Timeframe: Peri-Procedural

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 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.
IVL Technical Success (Post- Dilatation) IVL Technical Success (Post-dilatation)	30 Lesions
IVL Technical Success (Post- Dilatation) Freedom from Any Serious Flow-Limiting Dissection (D-F)	34 Lesions
IVL Technical Success (Post- Dilatation) Residual Stenosis ≤ 50%	31 Lesions

SECONDARY outcome

Timeframe: Peri-Procedural

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-Procedural

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 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.
Technical Success (Final) IVL Technical Success (Final)	25 lesions
Technical Success (Final) Residual Stenosis ≤ 30%	25 lesions
Technical Success (Final) Freedom from Any Serious Flow-Limiting Dissection (D-F)	35 lesions

SECONDARY outcome

Timeframe: 6 Months Post-Procedure

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

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Months Post-Procedure

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

Outcome data not reported

SECONDARY outcome

Timeframe: 12-Months Post Procedure

• 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

Outcome data not reported

Adverse Events

Single-arm

Serious events: 8 serious events

Other events: 17 other events

Deaths: 1 deaths

Serious adverse events

Measure	Single-arm 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 • 30-Days
Eye disorders Cataract	2.9% 1/35 • Number of events 1 • 30-Days
Gastrointestinal disorders Intestinal ischaemia	2.9% 1/35 • Number of events 1 • 30-Days
General disorders Chest pain	2.9% 1/35 • Number of events 1 • 30-Days
Infections and infestations Cellulitis	2.9% 1/35 • Number of events 1 • 30-Days
Injury, poisoning and procedural complications Thoracic vertebral fracture	2.9% 1/35 • Number of events 1 • 30-Days
Injury, poisoning and procedural complications Vascular procedure complications	5.7% 2/35 • Number of events 2 • 30-Days
Surgical and medical procedures Toe amputation	2.9% 1/35 • Number of events 1 • 30-Days
Vascular disorders Orthostatic hypotension	2.9% 1/35 • Number of events 1 • 30-Days
Vascular disorders Peripheral artery restenosis	2.9% 1/35 • Number of events 1 • 30-Days

Other adverse events

Measure	Single-arm 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.
Injury, poisoning and procedural complications Vascular procedure complications	31.4% 11/35 • Number of events 12 • 30-Days
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 2/35 • Number of events 2 • 30-Days
Nervous system disorders Syncope	5.7% 2/35 • Number of events 2 • 30-Days
Surgical and medical procedures Toe amputation	5.7% 2/35 • Number of events 2 • 30-Days

Additional Information

Kavita Arjungi

Shockwave Medical

Phone: 1-510-279-4262

Email: karjungi@shockwavemedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place