Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

June 25, 2013 updated by: Yujie Zhou, Capital Medical University

Effect of Rotational Atherectomy on Balloon-resistant Calcified Coronary Lesion the During a Long-term Follow-up Study

The optimal treatment of calcified coronary lesion remained to be elucidated. A Prospective, randomized controlled trial was perform to explore the immediate effect and long-term outcome of rotational atherectomy in patients with balloon resistant coronary lesion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The inclusion criteria included patients presenting drug-resistant angina pectoris who underwent balloon resistant angioplasty.

The exclusion criteria included:

  1. Acute myocardial infarction within the 28 days;
  2. Intolerance to aspirin, clopidogrel, contrast media, or statins;
  3. Angiographic visible thrombus, or dissection;
  4. Left ventricular ejection fraction (LVEF)<35%;
  5. Any type of cancer
  6. Hemorrhagic stroke

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

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
    • Beijing
      • Beijing, Beijing, China, 100029
        • Xinguo Wang

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Drug-resistant angina pectoris
  • Balloon resistant and angiographic calcified coronary lesion

Exclusion Criteria:

  • Acute myocardial infarction within 28 days;
  • Intolerance to aspirin, clopidogrel, contrast media, or statins;
  • Angiographic visible thrombus, dissection;
  • LVEF <35%;
  • Any type of cancer;
  • Hemorrhagic stroke

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotablator

Rotablator plus conventional angioplasty and/or stenting was performed in 120 patients in the R group.

Rotablator using 140, -160, 000 rpm, small rota burr (burr-to-artery ratio, 0.6:1), avoid drop of >5000 rpm for 5s.

Conventional intervention will be performed in the rotablator group. All subjects were given 100 mg/day aspirin and clopidogrel (300 mg loading dose and 75 mg/day maintenance dosage) at least 24 h before the procedure. A cutting balloon, buddy wire balloon, buddy wire, or DES (including sirolimus-eluting stent, paclitaxel-eluting stent, everolimus-eluting stent,zotarolimus-eluting stent) was implemented at the discretion of the operator in both groups.
Device: Rotablator
Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.
Other Names:
  • Rotational atherectomy; High-speed rotational atherectomy
Procedure: conventional angioplasty
Conventional angioplasty was used in both arms.
Other Names:
  • percutaneous transluminal coronary angioplasty
Procedure: stenting
Stenting was implanted in both arms.
Other Names:
  • Implantation of coronary stent
Device: Cutting balloon
Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.
Other Names:
  • Flextome Cutting balloon
Drug: Aspirin
Aspirin will be administrated in participants in both arms.
Other Names:
  • Bayaspirin, 100mg, tablet, oral, Germany
Drug: Clopidogrel
Clopidogrel will be administrated to participants in both arms.
Other Names:
  • Plavix, Clopidogrel Bisulfate, 100mg, tablet, oral
Device: Paclitaxel-eluting stent
Paclitaxel-eluting stent will be used in both arms.
Other Names:
  • Taxus
Device: zotarolimus-eluting stent
Zotarolimus-eluting stent will be implanted in participants in both arms.
Other Names:
  • Resolute, Medtronic CardioVascular
Device: Everolimus-eluting stent
Everolimus-eluting stent will be used in both arms.
Other Names:
  • Xience V
Device: Sirolimus-eluting stent
Sirolimus-eluting stent will be used in both arms.
Other Names:
  • Firebird, Shanghai, China
Active Comparator: Conventional

Conventional angioplasty and/or stenting was performed in 120 patients in the C group.

Conventional intervention without rotablator was performed in the C group. All subjects were given 100 mg/day aspirin and clopidogrel (300 mg loading dose and 75 mg/day maintenance dosage) at least 24 h before the procedure. A cutting balloon, buddy wire balloon, buddy wire, or DES (including sirolimus-eluting stent, paclitaxel-eluting stent, everolimus-eluting stent,zotarolimus-eluting stent) was implemented at the discretion of the operator in both groups.
Procedure: conventional angioplasty
Conventional angioplasty was used in both arms.
Other Names:
  • percutaneous transluminal coronary angioplasty
Procedure: stenting
Stenting was implanted in both arms.
Other Names:
  • Implantation of coronary stent
Device: Cutting balloon
Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.
Other Names:
  • Flextome Cutting balloon
Drug: Aspirin
Aspirin will be administrated in participants in both arms.
Other Names:
  • Bayaspirin, 100mg, tablet, oral, Germany
Drug: Clopidogrel
Clopidogrel will be administrated to participants in both arms.
Other Names:
  • Plavix, Clopidogrel Bisulfate, 100mg, tablet, oral
Device: Paclitaxel-eluting stent
Paclitaxel-eluting stent will be used in both arms.
Other Names:
  • Taxus
Device: zotarolimus-eluting stent
Zotarolimus-eluting stent will be implanted in participants in both arms.
Other Names:
  • Resolute, Medtronic CardioVascular
Device: Everolimus-eluting stent
Everolimus-eluting stent will be used in both arms.
Other Names:
  • Xience V
Device: Sirolimus-eluting stent
Sirolimus-eluting stent will be used in both arms.
Other Names:
  • Firebird, Shanghai, China

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events including death, myocardial infarction (MI), target vessel revascularization (TVR) and coronary artery bypass grafting
Time Frame: Participants will be followed for 2 years after the procedure, an expected average of 24 months.
Follow-up study was performed by experienced doctors through telephone interviews or clinic visits at 1, 3, 6, and 12 months after the procedure, and at every 6 months thereafter. The average duration of follow up was anticipated to be 24 months.
Participants will be followed for 2 years after the procedure, an expected average of 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In hospital endpoints including death, periprocedural MI
Time Frame: In hospital endpoints were doucmented for the duration of hospital stay, an expected average 2 weeks.
Baseline characteristics were measured on the day of admission to the hospital(baseline).An electrocardiogram was performed 2 h after the procedure. electrocardiograms were required to document any suspicious cardiac ischemic episodes. If any cardiac biomarker elevation was noted after the procedure, further measurements were performed as needed. During their hospital stays, patients were clinically monitored for the occurrence of any adverse events and the need for any additional coronary interventional treatment (In hospital endpoints including death, periprocedural MI).
In hospital endpoints were doucmented for the duration of hospital stay, an expected average 2 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural complications
Time Frame: Participants will be followed during the process of the procedure, an expected average of 4 hours.
Procedural complications including death, vessel perforation, dissection, ventricular fibrillation, no reflow, side branch loss. The specific unit of measure will be number of participants with any above mentioned procedural complications.
Participants will be followed during the process of the procedure, an expected average of 4 hours.

Collaborators and Investigators

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

Sponsor

Capital Medical University

Collaborators

Beijing Anzhen Hospital

Investigators

  • Study Chair: Yujie Zhou, MD.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Estimate)

June 27, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERBRCAL

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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