Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)
|ClinicalTrials.gov Identifier: NCT03328949|
Recruitment Status : Completed
First Posted : November 1, 2017
Last Update Posted : June 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: IVL Coronary Lithotripsy System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Intravascular Coronary Lithotripsy System|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries|
|Actual Study Start Date :||May 18, 2018|
|Actual Primary Completion Date :||March 26, 2019|
|Actual Study Completion Date :||April 25, 2019|
Experimental: IVL Coronary Lithotripsy System
All enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement.
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).
- In-hospital major adverse cardiac events (MACE) [ Time Frame: 1 day post-procedure ]
The primary safety endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following:
- Cardiac death
- MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave
- TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
- Residual stenosis (<50%) after stenting [ Time Frame: Procedural ]Performance will be assessed by the ability of the Lithotripsy System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE. Each patient that achieves both of these requirements will be considered a "clinical success", and the rate of clinical success among subjects will be evaluated.
- Angiographic success [ Time Frame: Procedural ]Angiographic success defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
- Cardiac Death [ Time Frame: 30 days ]Cardiac death at 30 days.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328949
|Institut Hospitalier Jacques Cartier|
|Universitaets-Herzzentrum Freiburg- Bad Krozingen|
|Bad Krozingen, Germany|
|UKGM Universitaetsklinikum Giessen|
|AOU Careggi SOD Interventistica|
|San Raffaelle Hospital|
|Thorax Center, Erasmus MC|
|Isala Zeikenhuis- Hartecentrum|
|Hospital Universitario San Carlos|
|Uppsala University Hospital|
|King's College Hospital|
|London, United Kingdom|
|Oxford University Hospitals, John Radcliffe Hospital|
|Oxford, United Kingdom|
|Principal Investigator:||Jean Fajadet, MD||Clinic Pasteur|
|Principal Investigator:||Carlo DiMario, MD||University of Florence|