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

NCT ID: NCT02716363

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2020-08-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Rotational Atherectomy by Rotablator

Intervention Type: DEVICE

Interventions

Rotational Atherectomy by Rotablator

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hyeon-Cheol Gwon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hyoen-Cheol Gwon, MD,PhD

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Hyoen-Cheol Gwon, MD,PhD

Role: primary

hcgwon@skku.edu

82-2-3410-3418

Other Identifiers

2015-06-157

Identifier Type: -

Identifier Source: org_study_id