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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02716363
• Other study ID #: 2015-06-157
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2016
• Last updated: February 7, 2018
• Start date: November 1, 2015
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Rotational Atherectomy by Rotablator

Locations

Country	Name	City	State
Korea, Republic of	Hyoen-Cheol Gwon, MD,PhD	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite procedure-related complication	cardiac death, peri-procedural myocardial infarction (CK-MB rise > X10 URL), coronary perforation, cardiopulmonary resuscitation, hemodynamic support (IABP, PCPS), or emergency surgery	2 years
Secondary	Procedure duration		from guiding catheter to final angiography, an average of 1 day
Secondary	Fluoroscopy time		from guiding catheter to final angiography, an average of 1 day
Secondary	Target vessel failure	Defined as a composite of cardiac death, myocardial infarction , or target vessel revascularization	1,6 and 12months
Secondary	Final in-stent minimal lumen area by IntraVascular UltraSound		1,6 and 12months