Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

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.

Conditions

• Coronary Artery Disease

Interventions

DEVICE

Rotablator

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

PROCEDURE

conventional angioplasty

Conventional angioplasty was used in both arms.

PROCEDURE

stenting

Stenting was implanted in both arms.

DEVICE

Cutting balloon

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

DRUG

Aspirin

Aspirin will be administrated in participants in both arms.

DRUG

Clopidogrel

Clopidogrel will be administrated to participants in both arms.

DEVICE

Paclitaxel-eluting stent

Paclitaxel-eluting stent will be used in both arms.

DEVICE

zotarolimus-eluting stent

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

DEVICE

Everolimus-eluting stent

Everolimus-eluting stent will be used in both arms.

DEVICE

Sirolimus-eluting stent

Sirolimus-eluting stent will be used in both arms.

Sponsors & Collaborators

• Beijing Anzhen Hospital

  collaborator OTHER

• Capital Medical University

  lead OTHER

Principal Investigators

• Yujie Zhou, MD.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• China

Study Locations