NCT02369848

Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated to generate sonic shockwave energy within the target treatment site and disrupt calcium within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low balloon pressure. Up to sixty (60) subjects will be enrolled and treated with Lithoplasty to yield thirty (51) evaluable subjects complete the study assuming a 15% lost to follow-up rate.

Detailed description

Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated for lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to sixty (60) subjects will be enrolled at up to 8 centers in Europe and New Zealand to yield at least 51 evaluable subjects (assuming a lost-to-follow up rate of 15%). Subjects will be evaluated at discharge, 30 days, 6 months, and 12 months after enrollment/index procedure. Primary endpoints include safety and efficacy. Safety is a composite of new-onset Major Adverse Events through 30 days. Efficacy is target lesion patency at 12 months by duplex ultrasound defined as freedom from ≥50% restenosis.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Shockwave Lithoplasty System

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2015-02-24
• Last updated: 2018-04-18
• Results posted: 2018-04-18

Locations

8 sites across 3 countries: Austria, Germany, New Zealand

Regulatory

• FDA-regulated device study