NCT01887704

Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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: 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

• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-06-27
• Last updated: 2013-06-27

Locations

1 site across 1 country: China