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Disrupt CAD III Post-Approval Study (PAS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05021757
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
Shockwave Medical, Inc.

Brief Summary:
The study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the National Cardiovascular Data Registry (NCDR®) CathPCI Registry®.

Condition or disease Intervention/treatment
Coronary Artery Disease Myocardial Infarction Device: Shockwave C2 Coronary IVL

Detailed Description:
Subject Population: Patients ≥18 years of age with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study. Approximately 1000 patients in the CathPCI Registry® (including a minimum of 30 patients with permanent pacemakers [PPM] or implantable cardioverter defibrillators [ICDs]) will be enrolled. Subjects will be followed through discharge. A minimum of 150 patients will be followed 30 days post-procedure.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
Actual Study Start Date : March 10, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Group/Cohort Intervention/treatment
Disrupt CAD III PAS Cohort
Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort. A minimum of 150 patients with 30-day follow-up will be included in the PAS cohort.
Device: Shockwave C2 Coronary IVL
PCI procedure using a Shockwave C2 coronary IVL catheter




Primary Outcome Measures :
  1. All-cause death [ Time Frame: Up to hospital discharge, approximately 24-48 hours ]
  2. Procedure-related adverse events [ Time Frame: Up to hospital discharge, approximately 24-48 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study.
Criteria

Inclusion Criteria:

  1. Subject is ≥18 years of age
  2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
  3. Left ventricular ejection fraction >25% within 6 months
  4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  5. LAD, RCA or LCX (or of their branches) with:

    • Stenosis of ≥70% and <100% or
    • Stenosis ≥50% and <99% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
  6. The lesion length must not exceed 40 mm
  7. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)
  8. Evidence of calcification at the lesion site by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location

Exclusion Criteria:

  1. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
  2. New York Heart Association (NYHA) class III or IV heart failure
  3. Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
  4. Subjects in cardiogenic shock or with clinical evidence of acute heart failure
  5. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  6. Previous stent within target lesion (in-stent restenosis)

Information from the National Library of Medicine

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): NCT05021757


Contacts
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Contact: Randee Randoll 408-577-7856 rrandoll@shockwavemedical.com

Locations
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United States, District of Columbia
American College of Cardiology/National Cardiovascular Data Registry (NCDR) Recruiting
Washington, District of Columbia, United States, 20037
Contact: NCDR Product Support    800-257-4737    ncdr@acc.org   
Sponsors and Collaborators
Shockwave Medical, Inc.
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Responsible Party: Shockwave Medical, Inc.
ClinicalTrials.gov Identifier: NCT05021757    
Other Study ID Numbers: CP 64647
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Shockwave Medical, Inc.:
Intravascular Lithotripsy
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases