Clinical trial NCT01887704: Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion
Official title: Effect of Rotational Atherectomy on Balloon-resistant Calcified Coronary Lesion the During a Long-term Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
First posted: 2013-06-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiac Events including death, myocardial infarction (MI), target vessel revascularization (TVR) and coronary artery bypass grafting
timeFrame: Participants will be followed for 2 years after the procedure, an expected average of 24 months.
Secondary outcomes:
measure: In hospital endpoints including death, periprocedural MI
timeFrame: In hospital endpoints were doucmented for the duration of hospital stay, an expected average 2 weeks.
Other outcomes:
measure: Procedural complications
timeFrame: Participants will be followed during the process of the procedure, an expected average of 4 hours.
Locations:
city: Beijing
country: China
facility: Xinguo Wang
state: Beijing
Study officials:
name: Yujie Zhou, MD.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.