Disrupt CAD III With the Shockwave Coronary IVL System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03595176|
Recruitment Status : Active, not recruiting
First Posted : July 23, 2018
Results First Posted : June 21, 2021
Last Update Posted : June 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Myocardial Infarction||Device: Lithotripsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||431 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The Coronary IVL System is a proprietary balloon catheter system designed to enhance stent outcomes by enabling delivery of the calcium disrupting capability of lithotripsy prior to balloon dilatation at low pressures. The Coronary IVL System consists of an IVL Balloon Catheter with two integrated pairs of lithotripsy emitters, a Lithotripsy Generator, and Connector Cable.|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries|
|Actual Study Start Date :||January 9, 2019|
|Actual Primary Completion Date :||May 7, 2020|
|Estimated Study Completion Date :||April 2022|
Experimental: Coronary Lithotripsy System
All subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System
Deliver Lithotripsy to the target vessel prior to placing a coronary stent.
- Number of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure [ Time Frame: within 30 days of index procedure ]The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.
- Number of Participants With Procedural Success [ Time Frame: at discharge ]The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis <50% (core laboratory assessed) and without in-hospital MACE.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595176
|Study Chair:||Dean J Kereiakes, MD,FACC,FSCAI||The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital|
|Study Chair:||Gregg W Stone, MD,FACC,FSCAI||Columbia University|
|Study Chair:||Jonathan Hill, MD||Royal Brompton and Harefield NHS Foundation Trust|