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Rotational Atherectomy for Calcified lEsion By Smart Angioplasty Research Team (SMART-RACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02716363
Recruitment Status : Unknown
Verified February 2018 by Hyeon-Cheol Gwon, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : March 23, 2016
Last Update Posted : February 9, 2018
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center

Brief Summary:
Current guidelines recommend the use of rotational atherectomy (RA) for preparation of heavily calcified or severely fibrotic lesions that cannot be crossed by a balloon or adequately dilated before planned stenting (bailout situations). RA emerged in the 1990s as one of several tools to treat luminal obstruction via physical removal of plaque. Although initially explored as an alternative to balloon angioplasty, RA has shown favorable acute results in facilitating stent delivery and adequate expansion, particularly those affected by heavy calcification.Drug-eluting stents (DES) have substantially reduced re-stenosis rates in randomized clinical trials evaluating simple de novo coronary artery lesions and have also shown favorable results when implanted in complex lesions and patients, but higher event rates are observed when treating such subsets compared with simple lesions even with newer generation DES. However, there are limited data on evaluating the safety and effectiveness of RA followed by DES implantation for heavily calcified lesions in contemporary practice. Recent randomized controlled trial shows that RA before paclitaxel eluting stent implantation as first generation DES was not superior to paclitaxel eluting stent implantation without prior RA in reducing the primary endpoint of in-stent late luminal loss at 9 months, indicating that RA does not increase the efficacy of DES in patients with moderate to severe calcified lesions. However, there were only 15 (12.5%) crossovers from standard therapy to rotablation because of failure of balloon or stent delivery or suboptimal balloon expansion despite the use of a noncompliant balloon. Accordingly, procedural and fluoroscopy times were longer in the elective RA and procedural complications occurred equally in both elective RA and bailout RA. These findings might cause by a substantial portion of enrolled population have moderate calcified lesions, but not severe calcified lesions. In particular, everolimus-eluting stent (EES) as newer generation DES could act synergistically in heavily calcified lesions as RA could avert stent coating damage and EES could effectively suppress neointimal proliferation. Therefore, we compare in-hospital and long-term efficacy or safety of elective RA versus bailout RA and low-volume operator versus high-volume operator in patients with severe calcified lesions treated with EES.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Rotational Atherectomy by Rotablator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SMart Angioplasty Research Team: A Multi-center, Open Study to Evaluation the Efficacy and Safety of Rotational Atherectomy With Drug Eluting Stent for Calcified LEsion in Korea (SMART-RACE) Trial
Study Start Date : November 1, 2015
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: Device : Rotablator
We compare in-hospital and long-term efficacy or safety of elective Rotational Atherectomy versus bailout Rotational Atherectomy and low-volume operator versus high-volume operator in patients with severe calcified lesions treated.
Device: Rotational Atherectomy by Rotablator

Primary Outcome Measures :
  1. A composite procedure-related complication [ Time Frame: 2 years ]
    cardiac death, peri-procedural myocardial infarction (CK-MB rise > X10 URL), coronary perforation, cardiopulmonary resuscitation, hemodynamic support (IABP, PCPS), or emergency surgery

Secondary Outcome Measures :
  1. Procedure duration [ Time Frame: from guiding catheter to final angiography, an average of 1 day ]
  2. Fluoroscopy time [ Time Frame: from guiding catheter to final angiography, an average of 1 day ]
  3. Target vessel failure [ Time Frame: 1,6 and 12months ]
    Defined as a composite of cardiac death, myocardial infarction , or target vessel revascularization

  4. Final in-stent minimal lumen area by IntraVascular UltraSound [ Time Frame: 1,6 and 12months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject must be at least 19 years of age
  • Angiographically proven coronary artery disease
  • Patients underwent Rotational Atherectomy
  • He/she or his/her legally authorized representative provides written informed consent
  • Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm

Exclusion Criteria:

  • Cardiac arrest before the procedure
  • Pregnancy or breast feeding
  • Thrombotic lesion
  • Saphenous vein graft
  • Unprotected left main lesion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02716363

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Korea, Republic of
Hyoen-Cheol Gwon, MD,PhD Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyoen-Cheol Gwon, MD,PhD    82-2-3410-3418   
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center Identifier: NCT02716363    
Other Study ID Numbers: 2015-06-157
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases