NCT03328949

Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)

Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.

Detailed description

The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure. Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	IVL Coronary Lithotripsy System	The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).

Timeline

• Start date: 2018-05-18
• Primary completion: 2019-03-26
• Completion: 2019-04-25
• First posted: 2017-11-01
• Last updated: 2019-11-19
• Results posted: 2019-11-08

Locations

15 sites across 9 countries: Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom