Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD

Status Completed

Clinical Trial Summary

Clinical Trial Description

Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. The Shockwave Medical Peripheral Lithoplasty System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to 400 subjects at 60 sites in Europe, the United States and New Zealand. Subjects will be followed through discharge, 30 days, and 6, 12 and 24 months. DUS assessments will be completed at 12 and 24 months. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. Subjects who do not meet the randomized study inclusion and exclusion criteria, but meet the inclusion and exclusion criteria for the observational study may be enrolled in the observational study. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 22 months. Subjects in the observational study will be followed through hospital discharge. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria. Results for the observational study will be reported in a separate record under NCT05881421. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02923193
Study type	Interventional
Source	Shockwave Medical, Inc.
Contact
Status	Completed
Phase	N/A
Start date	February 22, 2017
Completion date	June 2, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06032065` - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)	Phase 3
Active, not recruiting	`NCT03987061` - MOTIV Bioresorbable Scaffold in BTK Artery Disease	N/A
Recruiting	`NCT03506633` - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients	N/A
Active, not recruiting	`NCT03506646` - Dietary Nitrate Supplementation and Thermoregulation	N/A
Active, not recruiting	`NCT04677725` - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting	`NCT05961943` - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients	N/A
Recruiting	`NCT06047002` - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed	`NCT03185052` - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach	N/A
Recruiting	`NCT05992896` - A Study of Loco-Regional Liposomal Bupivacaine Injection	Phase 4
Completed	`NCT04635501` - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial	N/A
Recruiting	`NCT04584632` - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery	N/A
Withdrawn	`NCT03994185` - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease	N/A
Withdrawn	`NCT03538392` - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting	`NCT02915796` - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty	Phase 1
Active, not recruiting	`NCT02900924` - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed	`NCT02901847` - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.	N/A
Not yet recruiting	`NCT02387450` - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication	Phase 2/Phase 3
Withdrawn	`NCT02126540` - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries	N/A
Not yet recruiting	`NCT02455726` - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease	N/A
Completed	`NCT02384980` - Saving Life and Limb: FES for the Elderly With PAD	Phase 1

Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms