Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial (Short-Cut)

Baim Institute for Clinical Research

Status

Enrolling

Conditions

Treatment in Calcified Coronary Disease

Treatments

Device: Intravascular Lithotripsy

Device: Cutting Balloon

Study type

Interventional

Funder types

Other

Identifiers

NCT06089135

BBC22

Details and patient eligibility

About

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.

Full 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.

Enrollment

410 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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
2. The target lesion is a de novo native coronary lesion
3. The target vessel is a native coronary artery with either:
  1. A stenosis > 70%; or,
  2. 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
4. The reference diameter of the target vessel is > 2.5mm and < 4.0 mm at the lesion site
5. The target lesion has evidence of significant calcium at the lesion site defined either as,
  1. The presence of radiopacities involving both sides of the arterial wall > 5mm and involving the target lesion on angiography
  2. 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:

1. Patient is pregnant
2. Patient is actively participating in another clinical trial
3. Known LVEF < 25%
4. Ongoing Non-STEMI with rising biomarkers
5. Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamic support
6. Planned use in the randomized lesion of a bare metal stent or non-stent treatment only
7. Patient has a known allergy to contrast which cannot be adequately pre-treated
8. Patient has a history of bleeding or coagulopathy and is unable to receive blood transfusion if needed
9. Patient presents with STEMI
10. Patient is unable to tolerate dual anti-platelet therapy
11. Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days
  
  Angiographic Exclusion Criteria

1. Presence of large thrombus in the target vessel
2. Inability to pass coronary guidewire across the lesion
3. 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
4. The target lesion is within a coronary artery bypass graft
5. The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification
6. Coronary artery disease that requires surgical revascularization
7. Angiographic or imaging evidence of dissection in the target vessel prior to randomization
8. Investigator feels there is not equipoise regarding the treatment strategy