Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

Capital Medical University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Rotablator; Device: Paclitaxel-eluting stent; Drug: Clopidogrel; Procedure: conventional angioplasty; Procedure: stenting; Device: zotarolimus-eluting stent; Device: Cutting balloon; Drug: Aspirin; Device: Everolimus-eluting stent; Device: Sirolimus-eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01887704

ERBRCAL

Details and patient eligibility

About

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.

Full 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

Enrollment: 240 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Rotablator

Experimental group

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.

Treatment:

Device: Sirolimus-eluting stent

Device: Everolimus-eluting stent

Drug: Aspirin

Device: Cutting balloon

Device: zotarolimus-eluting stent

Procedure: stenting

Procedure: conventional angioplasty

Device: Paclitaxel-eluting stent

Drug: Clopidogrel

Device: Rotablator

Conventional

Active Comparator group

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.

Treatment:

Device: Sirolimus-eluting stent

Device: Everolimus-eluting stent

Drug: Aspirin

Device: Cutting balloon

Device: zotarolimus-eluting stent

Procedure: stenting

Procedure: conventional angioplasty

Device: Paclitaxel-eluting stent

Drug: Clopidogrel