Safety and Efficacy of Rotational Atherectomy (RA) in Coronary Dissection

August 18, 2014 updated by: Xijing Hospital

Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)

This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coronary artery dissection is a contraindication for the use of rotational atherectomy, since rotational atherectomy may propagate coronary dissection. In the presence of coronary dissection, conservative management is suggested for approximately 4 weeks to permit the dissection to heal prior to treatment with rotational atherectomy. However, a lot of patients have frequent angina attacks and some patients develop serious complications including abrupt vessel closure during this period. Thus, immediate strategies cope with coronary dissection induced by balloon dilation is needed for the early recovery of those patients. The present study was performed to compare the safety and efficacy of immediate RA and delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, Fourth Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 30 and 85 years old
  • nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure
  • Coronary artery dissection type A, B and type C according to the National Heart, Lung and Blood Institute (NHLBI) coronary dissection criteria

Exclusion Criteria:

  • acute myocardial infarction
  • unprotected left main stenosis
  • chronic total occlusion
  • saphenous vein graft lesion
  • cardiomyopathy
  • severe valvular heart disease
  • NYHA functional class IV heart failure at baseline
  • chronic renal failure on hemodialysis
  • severe lung and liver disease or cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotational atherectomy (RA)
Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection
Procedure: Immediate rotational atherectomy (RA)
Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.
Active Comparator: Delayed rotational atherectomy (RA)
Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection
Procedure: Delayed rotational atherectomy (RA)
Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause death
Time Frame: 4 years
cardiac death and non-cardiac death
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent thrombosis
Time Frame: 4 years
4 years
Left ventricular ejection fraction (LVEF)
Time Frame: 4 years
4 years
6-min walk distance (6MWD)
Time Frame: 4 years
4 years
angina class
Time Frame: 4 years
angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire
4 years
Non-fatal myocardial infarction
Time Frame: 4 years
4 years
Cardiac tamponade
Time Frame: 4 years
4 years
Stroke
Time Frame: 4 years
4 years
Target lesion revascularization
Time Frame: 4 years
4 years
New York Heart Association (NYHA) class IV heart failure
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Chengxiang Li, M.D., Ph.D., Department of Cardiolody, Xijing Hospital, Fourth Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAISE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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