Overview
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 lithotripsy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.
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 or intravascular lithotripsy will occur as follows in the 2 cohorts:
- After rotational atherectomy is safely completed In the rotational atherectomy arm
- After safe and successful wire crossing in patients in whom atherectomy is not planned.
The trial is designed to demonstrate non-inferiority between cutting balloon angioplasty and intravascular lithotripsy in each cohort with regards to the primary endpoint of post-procedural stent area as measured by intravascular imaging at the site of maximal calcification.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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
- 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