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NCT05966662 · ClinicalTrials.gov registry record · NA

Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)

A NA study of Coronary Artery Disease and Myocardial Infarction, sponsored by Shockwave Medical.

Completed
Registry status
NA
Development phase
145
Enrollment target
18
Study locations

NCT05966662: Completed NA study of Coronary Artery Disease and Myocardial Infarction, sponsored by Shockwave Medical.

NCT05966662 is a NA study of Coronary Artery Disease and Myocardial Infarction that has completed, run by Shockwave Medical. The registered enrollment target is 145 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (89% lower). The trial reports 18 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05966662, a NA study of Coronary Artery Disease and Myocardial Infarction, has completed, sponsored by Shockwave Medical.

COMPLETED
Registry status
NA
Development phase
145 participants
Enrollment target
18
Study locations

Study Summary

This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

Primary Outcome

Freedom from MACE within 30 days of the index procedure. MACE is defined as a composite occurrence of: cardiac death, myocardial infarction (MI), target vessel revascularization (TVR) after the completion of the index procedure.

Interventions

  • DEVICE IVL with Shockwave C2+ 2Hz Coronary IVL Catheter

Study Locations (18)

New York

  • Northwell Health/Lenox Hill - New York
  • St. Francis Hospital - Roslyn

Pennsylvania

  • UPMC Pinnacle Health - Harrisburg
  • WellSpan Health - York - York

Texas

  • Baylor Scott and White Research Institute - Dallas
  • Methodist Hospital - San Antonio

Alabama

  • Heart Center Research - Huntsville

California

  • Scripps Clinic - La Jolla

District of Columbia

  • Medstar Washington Hospital Center - Washington D.C.

Florida

  • Memorial Health - Hollywood

Georgia

  • Wellstar Kennestone Hospital - Marietta

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2023-12-08
Est. Completion 2025-12-19
Phase NA
Shockwave Medical

13 total trials

What the finished NCT05966662 record still lists

NCT05966662 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (89% lower).

The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which IVL with Shockwave C2+ 2Hz Coronary IVL Catheter is the first listed.

NCT05966662 lists 18 locations in 15 states (New York, Pennsylvania, Texas).

Frequently Asked Questions

What is clinical trial NCT05966662 about?

NCT05966662 is a clinical study titled "Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)". This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

What is the current status of trial NCT05966662?

This trial is currently completed. It is a NA study. The enrollment target is 145 participants. The study started on 2023-12-08. Estimated completion is 2025-12-19.

What conditions does trial NCT05966662 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Myocardial Infarction.

What interventions are being tested in trial NCT05966662?

The interventions under investigation include: IVL with Shockwave C2+ 2Hz Coronary IVL Catheter (DEVICE).

Who is sponsoring clinical trial NCT05966662?

This trial is sponsored by Shockwave Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05966662 being conducted?

This trial has 18 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Coronary Artery Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05966662's enrollment target sits among peer trials

145 134th of 219 higher than 86 of 219 other Coronary Artery Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05966662, the US trial registry maintained by the National Library of Medicine. NCT05966662 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.