Rotational Atherectomy for Calcified lEsion By Smart Angioplasty Research Team (SMART-RACE)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rotational Atherectomy by Rotablator
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
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
Sites / Locations
- Hyoen-Cheol Gwon, MD,PhDRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device : Rotablator
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Procedure duration
Fluoroscopy time
Target vessel failure
Defined as a composite of cardiac death, myocardial infarction , or target vessel revascularization
Final in-stent minimal lumen area by IntraVascular UltraSound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02716363
Brief Title
Rotational Atherectomy for Calcified lEsion By Smart Angioplasty Research Team (SMART-RACE)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2015 (undefined)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Device : Rotablator
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Rotational Atherectomy by Rotablator
Primary Outcome Measure Information:
Title
A composite procedure-related complication
Description
cardiac death, peri-procedural myocardial infarction (CK-MB rise > X10 URL), coronary perforation, cardiopulmonary resuscitation, hemodynamic support (IABP, PCPS), or emergency surgery
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Procedure duration
Time Frame
from guiding catheter to final angiography, an average of 1 day
Title
Fluoroscopy time
Time Frame
from guiding catheter to final angiography, an average of 1 day
Title
Target vessel failure
Description
Defined as a composite of cardiac death, myocardial infarction , or target vessel revascularization
Time Frame
1,6 and 12months
Title
Final in-stent minimal lumen area by IntraVascular UltraSound
Time Frame
1,6 and 12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hyoen-Cheol Gwon, MD,PhD
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoen-Cheol Gwon, MD,PhD
Phone
82-2-3410-3418
Email
hcgwon@skku.edu
12. IPD Sharing Statement
Learn more about this trial
Rotational Atherectomy for Calcified lEsion By Smart Angioplasty Research Team (SMART-RACE)
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