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Completed

NCT Number: NCT01887704

Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinguo Wang

Beijing, Beijing Municipality, 100029, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotablator

Device

Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.

Other names: Rotational atherectomy; High-speed rotational atherectomy

Conventional angioplasty

Procedure

Conventional angioplasty was used in both arms.

Other names: percutaneous transluminal coronary angioplasty

stenting

Procedure

Stenting was implanted in both arms.

Other names: Implantation of coronary stent

Cutting Balloon

Device

Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.

Other names: Flextome Cutting balloon

Aspirin

Drug

Aspirin will be administrated in participants in both arms.

Other names: Bayaspirin, 100mg, tablet, oral, Germany

clopidogrel

Drug

Clopidogrel will be administrated to participants in both arms.

Other names: Plavix, Clopidogrel Bisulfate, 100mg, tablet, oral

Paclitaxel-eluting stent

Device

Paclitaxel-eluting stent will be used in both arms.

Other names: Taxus

zotarolimus-eluting stent

Device

Zotarolimus-eluting stent will be implanted in participants in both arms.

Other names: Resolute, Medtronic CardioVascular

everolimus-eluting stent

Device

Everolimus-eluting stent will be used in both arms.

Other names: Xience V

Sirolimus-eluting stent

Device

Sirolimus-eluting stent will be used in both arms.

Other names: Firebird, Shanghai, China

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Beijing Anzhen Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2013
Registry last updated
Jun 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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