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

NCT02716363 | Unknown

• 1 other identifier: 2015-06-157
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Procedure duration

  from guiding catheter to final angiography, an average of 1 day

• Fluoroscopy time

  from guiding catheter to final angiography, an average of 1 day

• Target vessel failure

  1,6 and 12months

• Final in-stent minimal lumen area by IntraVascular UltraSound

  1,6 and 12months

Study Arms (1)

Device : Rotablator

EXPERIMENTAL

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

Interventions

Rotational Atherectomy by Rotablator DEVICE

Device : Rotablator

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Hyoen-Cheol Gwon, MD,PhD

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 23, 2016
• Study Start: November 1, 2015
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: February 9, 2018

Record last verified: 2018-02

Locations

KR (1)