Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial
NCT ID: NCT06089135
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
410 participants
INTERVENTIONAL
2023-12-31
2025-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Shockwave Coronary Lithoplasty Study
NCT02758379
Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)
NCT02650128
The Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter in the Pre-dilation of Coronary Artery Stenosis Lesions
NCT06926400
Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)
NCT07062471
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
NCT04865588
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intravascular Lithotripsy
Intravascular Lithotripsy
Intravascular lithotripsy will be performed with or without rotational atherectomy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.
Cutting Balloon
Cutting Balloon
Cutting Balloon therapy will be performed with or without rotational atherectomy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intravascular Lithotripsy
Intravascular lithotripsy will be performed with or without rotational atherectomy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.
Cutting Balloon
Cutting Balloon therapy will be performed with or without rotational atherectomy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
<!-- -->
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
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Robert W. Yeh, MD
UNKNOWN
Ajay Kirtane, MD
UNKNOWN
C. Michael Gibson, MS, MD
UNKNOWN
Kathleen Kearney, MD
UNKNOWN
Akiko Maehara, MD
UNKNOWN
Suzanne Baron, MD
UNKNOWN
Baim Institute for Clinical Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, United States
Christ Hospital
Cincinnati, Ohio, United States
UPMC
Pittsburgh, Pennsylvania, United States
Wellspan York Hospital
York, Pennsylvania, 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Dr. Mustafa Ahmed
Role: primary
Dr. Saroj Neupane
Role: primary
Dr. Rebecca Chester
Role: primary
Dr. Yousif Ahmad
Role: primary
Dr. Michael Nanna
Role: primary
Dr. Dmitri Baklanov
Role: primary
Dr. Szymon Wiernek
Role: primary
Dr. Nilay Patel
Role: primary
Dr. Robert Yeh
Role: primary
Dr. Khaldoon Alaswad
Role: primary
Dr. Krzysztof Drzymalski
Role: primary
Margaret McEntegart
Role: primary
Dr. Jarrod Frizzell
Role: primary
Dr. William Bachinsky
Role: primary
Dr. Rhian Davies
Role: primary
Dr. Nadia Sutton
Role: primary
Dr. Robert Stoler
Role: primary
Dr. Alpesh Shah
Role: primary
Dr. Srinivasa Potluri
Role: primary
Dr. Michael Ragosta
Role: primary
Dr. Kathleen Kearney
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BBC22
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.