Assessment of Cutting-Balloon Angioplasty with Drug-Eluting Stent in the Treatment of Calcified Coronary Lesions
Not Applicable
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009170
- Lead Sponsor
- Soonchunhyang University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
(1) Coronary artery disease including ISR or de novo lesion with a stenosis of = 70%
(2) Target lesion calcification (an arch of calcium at least 100 degrees) was confirmed by imaging studies
(3) A reference vessel diameter between 2.5 and 4.0mm and deemed suitable for PCI
Exclusion Criteria
(1) Extremely tortuous or angulated lesions
(2) Lesions with dissection before balloon pre-dilatation
(3) Lesions within the vein graft
(4) Extremely narrow lesions which need to rotational atherectomy
(5) ST-elevation MI(STEMI)
(6) Comorbidities which preclude the achievement of one year follow up
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Minimal stent cross-section area(CSA) with IVUS at calcium site
- Secondary Outcome Measures
Name Time Method All-cause death ;Cardiovascular death;Myocardial infarction(MI) ;Target vessel revascularization(TVR) ;Target lesion revascularization(TLR) ;Total procedure time of the index procedure;Total amount of contrast used in the index procedure;The total number of balloons used in the index procedure;Major adverse cardiac event(MACE)