NCT04585763

Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System

Prospective, Multi-center, Single-arm Study of the Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) System in Calcified Peripheral Arteries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, single-arm study of the M5+ Peripheral IVL system to treat calcified peripheral arteries.

Detailed description

The objective of this study is to assess the safety and performance of the Shockwave M5+ Peripheral IVL System to treat calcified peripheral arteries in pre-market countries, and to assess continued safety and effectiveness in the US. A minimum of 40 lesions in up to 40 subjects at up to 10 sites in Australia, New Zealand and the US will be enrolled with the aim of treating at least 20 target lesions with the 8.0 mm IVL catheter. A maximum of three target lesions may be treated per subject. Subjects with moderate and severely calcified iliac and femoropopliteal artery disease presenting with Rutherford Category 2 to 5. Approximately 6 months of enrollment at up to 10 sites in Australia, New Zealand and the US. Study subjects will be followed through discharge, 30 days, 6 and 12 months. Duplex Ultrasound (DUS) assessments will be completed at 12 months. Total anticipated study duration is 18 months. The primary safety endpoint is Major Adverse Events (MAE) at 30 days defined as: need for emergency surgical revascularization of target limb; unplanned target limb major amputation (above the ankle); symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization ; or perforations that require an intervention, including bail-out stenting. The primary performance endpoint is technical success defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion by angiographic core lab.

Conditions

• Peripheral Arterial Disease
• Vascular Disease, Peripheral

Interventions

Type	Name	Description
DEVICE	Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)	The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.

Timeline

• Start date: 2021-02-16
• Primary completion: 2021-08-25
• Completion: 2022-11-21
• First posted: 2020-10-14
• Last updated: 2024-01-03
• Results posted: 2023-08-14

Locations

8 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated device study