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

Not Applicable

Recruiting

• Conditions: Treatment in Calcified Coronary Disease
• Interventions: Device: Intravascular Lithotripsy; Device: Cutting Balloon

• Registration Number: NCT06089135
• Lead Sponsor: Baim Institute for Clinical Research

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 lithotripsy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.

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 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.

Study Timeline

• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-18
• Study Start: 2023-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 410

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

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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

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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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravascular Lithotripsy	Intravascular Lithotripsy	-
Cutting Balloon	Cutting Balloon	-

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	30 days	Post-procedural stent area at the point of maximum calcification as measured by intravascular imaging

Secondary Outcome Measures

Name	Time	Method
Peri-procedural Myocardial Infarction	within 48 hours of index procedure	Peri-procedural Myocardial Infarction as defined by Academic Research Consortium-2
Procedural Cost	Index procedure
Strategy success	Index procedure	Strategy success defined as stent delivery with a residual stenosis \< 20% in the absence of significant angiographic complication (e.g., severe dissection, perforation, abrupt closure or no-reflow and not having to use an alternative calcium modification device (e.g. atherectomy device or specialty balloon other than routine non-compliant balloon)
Procedural success	Index procedure	Procedural success defined as stent delivery with a residual stenosis \< 20% in the absence of significant angiographic complication (e.g. severe dissection, perforation, abrupt closure or no-reflow) with final TIMI 3 flow in the target vessel and the absence of intra-procedural death
Angiographic success	Index procedure	Angiographic success defined as stent delivery with a residual stenosis \< 20% in the absence of significant angiographic complication (e.g. severe dissection, perforation, abrupt closure or no-reflow)
In-hospital MACCE	hospitalization	In-hospital MACCE defined as composite of all-cause death, unplanned urgent target vessel revascularization, unplanned cardiothoracic surgery, spontaneous myocardial infarction or stroke/TIA at hospital discharge.
30 Day MACCE	30 days	30 Day MACCE defined as composite of all-cause death, unplanned target vessel revascularization, unplanned cardiothoracic surgery, spontaneous myocardial infarction or stroke/TIA at 30 days

Trial Locations

Locations (22)

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Wellspan York Hospital; 🇺🇸 York, Pennsylvania, United States

UAB Structural Heart and Valve Clinic; 🇺🇸 Birmingham, Alabama, United States

Banner Health; 🇺🇸 Phoenix, Arizona, United States

Honor Health; 🇺🇸 Scottsdale, Arizona, United States

UCSF Cardiology; 🇺🇸 San Francisco, California, United States

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Saint Luke's; 🇺🇸 Overland Park, Kansas, United States

Maine Medical Center; 🇺🇸 Portland, Maine, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medcial Center; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Health; 🇺🇸 Detroit, Michigan, United States

Capital Cardiology; 🇺🇸 Albany, New York, United States

Columbia Cardiology; 🇺🇸 New York, New York, United States

Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baylor Heart and Vascular Hospital; 🇺🇸 Dallas, Texas, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

Baylor Scott and White Health; 🇺🇸 Plano, Texas, United States

UVA Heart and Vascular Center; 🇺🇸 Charlottesville, Virginia, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Columbia University Medical Center/ NewYork Presbyterian Hospital; 🇺🇸 New York, New York, United States