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Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rotablator
conventional angioplasty
stenting
Cutting balloon
Aspirin
Clopidogrel
Paclitaxel-eluting stent
zotarolimus-eluting stent
Everolimus-eluting stent
Sirolimus-eluting stent
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xinguo Wang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rotablator

Conventional

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Major Adverse Cardiac Events including death, myocardial infarction (MI), target vessel revascularization (TVR) and coronary artery bypass grafting
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.

Secondary Outcome Measures

In hospital endpoints including death, periprocedural MI
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).

Full Information

First Posted
June 19, 2013
Last Updated
June 25, 2013
Sponsor
Capital Medical University
Collaborators
Beijing Anzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01887704
Brief Title
Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion
Official Title
Effect of Rotational Atherectomy on Balloon-resistant Calcified Coronary Lesion the During a Long-term Follow-up Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
Collaborators
Beijing Anzhen Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The inclusion criteria included patients presenting drug-resistant angina pectoris who underwent balloon resistant angioplasty. The exclusion criteria included: Acute myocardial infarction within the 28 days; Intolerance to aspirin, clopidogrel, contrast media, or statins; Angiographic visible thrombus, or dissection; Left ventricular ejection fraction (LVEF)<35%; Any type of cancer Hemorrhagic stroke

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
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotablator
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Rotablator
Other Intervention Name(s)
Rotational atherectomy; High-speed rotational atherectomy
Intervention Description
Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.
Intervention Type
Procedure
Intervention Name(s)
conventional angioplasty
Other Intervention Name(s)
percutaneous transluminal coronary angioplasty
Intervention Description
Conventional angioplasty was used in both arms.
Intervention Type
Procedure
Intervention Name(s)
stenting
Other Intervention Name(s)
Implantation of coronary stent
Intervention Description
Stenting was implanted in both arms.
Intervention Type
Device
Intervention Name(s)
Cutting balloon
Other Intervention Name(s)
Flextome Cutting balloon
Intervention Description
Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Bayaspirin, 100mg, tablet, oral, Germany
Intervention Description
Aspirin will be administrated in participants in both arms.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix, Clopidogrel Bisulfate, 100mg, tablet, oral
Intervention Description
Clopidogrel will be administrated to participants in both arms.
Intervention Type
Device
Intervention Name(s)
Paclitaxel-eluting stent
Other Intervention Name(s)
Taxus
Intervention Description
Paclitaxel-eluting stent will be used in both arms.
Intervention Type
Device
Intervention Name(s)
zotarolimus-eluting stent
Other Intervention Name(s)
Resolute, Medtronic CardioVascular
Intervention Description
Zotarolimus-eluting stent will be implanted in participants in both arms.
Intervention Type
Device
Intervention Name(s)
Everolimus-eluting stent
Other Intervention Name(s)
Xience V
Intervention Description
Everolimus-eluting stent will be used in both arms.
Intervention Type
Device
Intervention Name(s)
Sirolimus-eluting stent
Other Intervention Name(s)
Firebird, Shanghai, China
Intervention Description
Sirolimus-eluting stent will be used in both arms.
Primary Outcome Measure Information:
Title
Major Adverse Cardiac Events including death, myocardial infarction (MI), target vessel revascularization (TVR) and coronary artery bypass grafting
Description
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.
Time Frame
Participants will be followed for 2 years after the procedure, an expected average of 24 months.
Secondary Outcome Measure Information:
Title
In hospital endpoints including death, periprocedural MI
Description
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).
Time Frame
In hospital endpoints were doucmented for the duration of hospital stay, an expected average 2 weeks.
Other Pre-specified Outcome Measures:
Title
Procedural complications
Description
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.
Time Frame
Participants will be followed during the process of the procedure, an expected average of 4 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yujie Zhou, MD.
Official's Role
Study Chair
Facility Information:
Facility Name
Xinguo Wang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23351416
Citation
Chiang MH, Lee WL, Tsao CR, Chang WC, Su CS, Liu TJ, Liang KW, Ting CT. The use and clinical outcomes of rotablation in challenging cases in the drug-eluting stent era. J Chin Med Assoc. 2013 Feb;76(2):71-7. doi: 10.1016/j.jcma.2012.10.004. Epub 2012 Dec 29.
Results Reference
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PubMed Identifier
18550555
Citation
Roy P, Steinberg DH, Sushinsky SJ, Okabe T, Pinto Slottow TL, Kaneshige K, Xue Z, Satler LF, Kent KM, Suddath WO, Pichard AD, Weissman NJ, Lindsay J, Waksman R. The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents. Eur Heart J. 2008 Aug;29(15):1851-7. doi: 10.1093/eurheartj/ehn249. Epub 2008 Jun 11.
Results Reference
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Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

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