Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion
NCT ID: NCT01887704
Last Updated: 2013-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2010-01-31
2013-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Rotablator
Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.
conventional angioplasty
Conventional angioplasty was used in both arms.
stenting
Stenting was implanted in both arms.
Cutting balloon
Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.
Aspirin
Aspirin will be administrated in participants in both arms.
Clopidogrel
Clopidogrel will be administrated to participants in both arms.
Paclitaxel-eluting stent
Paclitaxel-eluting stent will be used in both arms.
zotarolimus-eluting stent
Zotarolimus-eluting stent will be implanted in participants in both arms.
Everolimus-eluting stent
Everolimus-eluting stent will be used in both arms.
Sirolimus-eluting stent
Sirolimus-eluting stent will be used in both arms.
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.
conventional angioplasty
Conventional angioplasty was used in both arms.
stenting
Stenting was implanted in both arms.
Cutting balloon
Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.
Aspirin
Aspirin will be administrated in participants in both arms.
Clopidogrel
Clopidogrel will be administrated to participants in both arms.
Paclitaxel-eluting stent
Paclitaxel-eluting stent will be used in both arms.
zotarolimus-eluting stent
Zotarolimus-eluting stent will be implanted in participants in both arms.
Everolimus-eluting stent
Everolimus-eluting stent will be used in both arms.
Sirolimus-eluting stent
Sirolimus-eluting stent will be used in both arms.
Interventions
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Rotablator
Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.
conventional angioplasty
Conventional angioplasty was used in both arms.
stenting
Stenting was implanted in both arms.
Cutting balloon
Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.
Aspirin
Aspirin will be administrated in participants in both arms.
Clopidogrel
Clopidogrel will be administrated to participants in both arms.
Paclitaxel-eluting stent
Paclitaxel-eluting stent will be used in both arms.
zotarolimus-eluting stent
Zotarolimus-eluting stent will be implanted in participants in both arms.
Everolimus-eluting stent
Everolimus-eluting stent will be used in both arms.
Sirolimus-eluting stent
Sirolimus-eluting stent will be used in both arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Balloon resistant and angiographic calcified coronary lesion
Exclusion Criteria
* Intolerance to aspirin, clopidogrel, contrast media, or statins;
* Angiographic visible thrombus, dissection;
* LVEF \<35%;
* Any type of cancer;
* Hemorrhagic stroke
18 Years
80 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
Capital Medical University
OTHER
Responsible Party
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Yujie Zhou
Proffesor
Principal Investigators
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Yujie Zhou, MD.
Role: STUDY_CHAIR
Locations
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Xinguo Wang
Beijing, Beijing Municipality, China
Countries
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References
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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.
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.
Other Identifiers
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ERBRCAL
Identifier Type: -
Identifier Source: org_study_id
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