NCT05881421

DISRUPT PAD III Observational Study

Prospective Multi-Center, Post-Market, Observational Study (OS) of the Shockwave Medical, Inc. Intravascular Lithotripsy System in Peripheral Arteries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,373 (actual)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System. The objective of this study was to assess the real-world acute performance of IVL in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the RCT. The study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the S4 IVL catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (BTK) lesions. Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.

Conditions

• Peripheral Arterial Disease

Timeline

• Start date: 2017-11-16
• Primary completion: 2021-06-10
• Completion: 2021-06-10
• First posted: 2023-05-31
• Last updated: 2023-05-31

Locations

30 sites across 3 countries: United States, Germany, New Zealand