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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P200039 / PAS002 |
| Date Original Protocol Accepted |
04/09/2021
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| Date Current Protocol Accepted |
|
| Study Name |
DISRUPT CAD III Cont f/u Study
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| Device Name |
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Study Design: The overall study design for the CFS is unchanged from the pivotal portion of the IDE study.
The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Coronary IVL System in de novo, calcified, stenotic coronary arteries prior to stenting.
Disrupt CAD III will be conducted as a staged pivotal study. During the first stage, up to 25 sites in the United States will be initiated to enroll up to 75 subjects (25 roll-in, 50 pivotal). Sites outside of the US may be initiated during the initial stage and do not count toward the 25 site limit or the 75 subject limit. The first 30 pivotal subjects enrolled in the study will be included in the safety assessment and their data analyzed. Results of this early safety analysis will be sent to the FDA as an IDE supplement with a request to expand the study to 50 sites worldwide. The first 25 US sites will continue to enroll up to a total of 75 subjects during FDA’s review of this IDE Supplement.
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| Study Population |
The study population for the Disrupt CAD III CFS is comprised of the 384 pivotal subjects enrolled in the Disrupt CAD III IDE study. Subjects in the IDE were enrolled per eligibility criteria outlined in Section 7.2. There are no new enrollments in the Disrupt CAD III CFS.
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| Sample Size |
The process for the original sample size determination is outlined in Section 9.2. There are no new enrollments required for the CFS and no new hypothesis testing.
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| Key Study Endpoints |
The primary safety endpoint for the CFS is freedom from MACE at 12 and 24 months, reported descriptively.
Other endpoints to be assessed through 2 years post-procedure include the rate of: (1) target lesion failure (TLF) and (2) all death, cardiac death, MI, TV-MI, nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) at 6, 12 and 24 months.
Robust independent adjudication of events (i.e., Clinical Events Committee) will be maintained throughout the CFS, unmodified from the pivotal portion of the study.
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| Follow-up Visits and Length of Follow-up |
Follow-up within 12-24 hours post procedure or at discharge; follow-up at 30 days; follow-up at 6, 12, 24 months
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
384
|
| Actual Number of Sites Enrolled |
47
|
| Patient Follow-up Rate |
93.5%
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| Final Effect Findings |
Final Safety and Effectiveness Findings (Combined)
The primary endpoint was Major Adverse Cardiac Events (MACE), which was a composite of cardiac death, non-Q-wave myocardial infarction (MI), Q-wave MI, and target vessel revascularization.
The MACE rate was 7.0%, 7.8%, 10.2%, 13.6% and 18.9% for the timepoints of in-hospital, 30 days, and 6, 12, and 24 months, respectively, with major contributing components including non-Q-wave myocardial infarction (MI) and target vessel revascularization.
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| Study Strengths & Weaknesses |
Strengths:
Study monitoring and adjudication
Good follow up compliance to 24 years
Weaknesses:
Single arm study
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| Recommendations for Labeling Changes |
Yes
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