Status:
RECRUITING
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial
Lead Sponsor:
Baim Institute for Clinical Research
Collaborating Sponsors:
Robert W. Yeh, MD
Ajay Kirtane, MD
Conditions:
Treatment in Calcified Coronary Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The Short-Cut trial is a prospective, investigator-initiated, multicenter, randomized controlled trial that is designed to compare the efficacy of cutting balloon angioplasty vs. intravascular lithotr...
Detailed Description
The trial will be composed of two cohorts: * Patients treated with up-front rotational atherectomy * Patients in whom atherectomy is not planned Randomization to either cutting balloon angioplasty o...
Eligibility Criteria
Inclusion
- 1\. Subject is \> 21 years old 2. Subject with an indication for PCI for the treatment of a) stable coronary artery disease; b) unstable angina; or c) NSTEMI with evidence of down-trending biomarkers 3. Subject is willing and able to provide informed written consent Angiographic Inclusion Criteria
- The target lesion is a de novo native coronary lesion
- The target vessel is a native coronary artery with either:
- A stenosis \> 70%; or,
- A stenosis \> 50% and \<70% with evidence of ischemia via either positive stress test, FFR value \< 0.80 or RFR/iFR/DFR value \< 0.89
- The reference diameter of the target vessel is \> 2.5mm and \< 4.0 mm at the lesion site
- The target lesion has evidence of significant calcium at the lesion site defined either as,
- The presence of radiopacities involving both sides of the arterial wall \> 5mm and involving the target lesion on angiography
- the presence of \> 270o arc of superficial calcium on intravascular imaging with a length \> 5mm or the presence of 360o arc of superficial calcium
Exclusion
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- Patient is pregnant
- Patient is actively participating in another clinical trial
- Known LVEF \< 25%
- Ongoing Non-STEMI with rising biomarkers
- Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamic support
- Planned use in the randomized lesion of a bare metal stent or non-stent treatment only
- Patient has a known allergy to contrast which cannot be adequately pre-treated
- Patient has a history of bleeding or coagulopathy and is unable to receive blood transfusion if needed
- Patient presents with STEMI
- Patient is unable to tolerate dual anti-platelet therapy
- Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days
- Angiographic Exclusion Criteria
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- Presence of large thrombus in the target vessel
- Inability to pass coronary guidewire across the lesion
- The target vessel has excessive tortuosity (Defined as presence of 2+ bends \> 90o or 3+ bends \> 75o) or other anatomic considerations that precludes intravascular imaging
- The target lesion is within a coronary artery bypass graft
- The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification
- Coronary artery disease that requires surgical revascularization
- Angiographic or imaging evidence of dissection in the target vessel prior to randomization
- Investigator feels there is not equipoise regarding the treatment strategy
Key Trial Info
Start Date :
December 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT06089135
Start Date
December 31 2023
End Date
December 30 2025
Last Update
April 6 2025
Active Locations (22)
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1
UAB Structural Heart and Valve Clinic
Birmingham, Alabama, United States, 35233
2
Banner Health
Phoenix, Arizona, United States, 85012
3
Honor Health
Scottsdale, Arizona, United States, 13400
4
UCSF Cardiology
San Francisco, California, United States, 94117