Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887704
• Other study ID #: ERBRCAL
• Status: Completed
• Phase: N/A
• First received: June 19, 2013
• Last updated: June 25, 2013
• Start date: January 2010
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.
• Clopidogrel
Clopidogrel will be administrated to participants in both arms.

Device:
• Paclitaxel-eluting stent
Paclitaxel-eluting stent will be used in both arms.
• zotarolimus-eluting stent
Zotarolimus-eluting stent will be implanted in participants in both arms.
• Everolimus-eluting stent
Everolimus-eluting stent will be used in both arms.
• Sirolimus-eluting stent
Sirolimus-eluting stent will be used in both arms.

Locations

Country	Name	City	State
China	Xinguo Wang	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Capital Medical University	Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedural complications	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.	Participants will be followed during the process of the procedure, an expected average of 4 hours.	Yes
Primary	Major Adverse Cardiac Events including death, myocardial infarction (MI), target vessel revascularization (TVR) and coronary artery bypass grafting	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.	Participants will be followed for 2 years after the procedure, an expected average of 24 months.	Yes
Secondary	In hospital endpoints including death, periprocedural MI	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).	In hospital endpoints were doucmented for the duration of hospital stay, an expected average 2 weeks.	Yes