Clinical trial NCT06089135: Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial
Official title: Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial (Short-Cut)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment in Calcified Coronary Disease
Keywords: Intravascular Lithoplasty
Cutting Balloon
Calcified Coronary Disease
Percutaneous Coronary Intervention
Lead sponsor: Baim Institute for Clinical Research
Sponsor class: OTHER
Collaborators: name: Robert W. Yeh, MD
name: Ajay Kirtane, MD
name: C. Michael Gibson, MS, MD
name: Kathleen Kearney, MD
name: Akiko Maehara, MD
name: Suzanne Baron, MD
First posted: 2023-10-18
Enrollment: 410
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

  1. The target lesion is a de novo native coronary lesion
  2. 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
  3. The reference diameter of the target vessel is \> 2.5mm and \< 4.0 mm at the lesion site
  4. 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

Primary outcomes:
measure: Primary Endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Procedural Cost
timeFrame: Index procedure
measure: Procedural success
timeFrame: Index procedure
measure: Angiographic success
timeFrame: Index procedure
measure: Strategy success
timeFrame: Index procedure
measure: Peri-procedural Myocardial Infarction
timeFrame: within 48 hours of index procedure
measure: In-hospital MACCE
timeFrame: hospitalization
measure: 30 Day MACCE
timeFrame: 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Structural Heart and Valve Clinic
state: Alabama
city: Phoenix
country: United States
facility: Banner Health
state: Arizona
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: San Francisco
country: United States
facility: UCSF Cardiology
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Overland Park
country: United States
facility: Saint Luke's
state: Kansas
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medcial Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Albany
country: United States
facility: Capital Cardiology
state: New York
city: New York
country: United States
facility: Columbia Cardiology
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/ NewYork Presbyterian Hospital
state: New York
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: York
country: United States
facility: Wellspan York Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Plano
country: United States
facility: Baylor Scott and White Health
state: Texas
city: Charlottesville
country: United States
facility: UVA Heart and Vascular Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
citation: Shah M, Najam O, Bhindi R, De Silva K. Calcium Modification Techniques in Complex Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2021 May;14(5):e009870. doi: 10.1161/CIRCINTERVENTIONS.120.009870. Epub 2021 Jan 14.
citation: Allali A, Toelg R, Abdel-Wahab M, Hemetsberger R, Kastrati A, Mankerious N, Traboulsi H, Elbasha K, Rheude T, Landt M, Geist V, Richardt G. Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions: The PREPARE-CALC-COMBO study. Catheter Cardiovasc Interv. 2022 Nov;100(6):979-989. doi: 10.1002/ccd.30423. Epub 2022 Oct 19.
citation: Furuichi S, Tobaru T, Asano R, Watanabe Y, Takamisawa I, Seki A, Sumiyoshi T, Tomoike H. Rotational atherectomy followed by cutting-balloon plaque modification for drug-eluting stent implantation in calcified coronary lesions. J Invasive Cardiol. 2012 May;24(5):191-5.
citation: Abdel-Wahab M, Toelg R, Byrne RA, Geist V, El-Mawardy M, Allali A, Rheude T, Robinson DR, Abdelghani M, Sulimov DS, Kastrati A, Richardt G. High-Speed Rotational Atherectomy Versus Modified Balloons Prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007415. doi: 10.1161/CIRCINTERVENTIONS.118.007415.
citation: Mangieri A, Nerla R, Castriota F, Reimers B, Regazzoli D, Leone PP, Gasparini GL, Khokhar AA, Laricchia A, Giannini F, Casale F, Bezzeccheri A, Briguori C, Colombo A. Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial. Catheter Cardiovasc Interv. 2023 Mar;101(4):798-805. doi: 10.1002/ccd.30603. Epub 2023 Feb 25.
citation: Kereiakes DJ, Hill JM, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Arteries: 2-Year Results-Disrupt CAD III Study. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2472-2474. doi: 10.1016/j.jcin.2023.07.010. Epub 2023 Sep 6. No abstract available.