Comparison of the Incidence of Slow Flow Following Rotational Atherectomy to Severely Calcified Coronary Artery Lesions between Short Single Session Versus Long Single Session: A Randomized Controlled Trial.
Not Applicable
Recruiting
- Conditions
- Coronary Artery Disease
- Registration Number
- JPRN-UMIN000047231
- Lead Sponsor
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
1. Less than 20 years-old. 2. Contraindication in instructions-for-use of Rotablator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Slow flow just following rotational atherectomy. Slow flow is defined as [(initial TIMI-frame count)x1.1 minus (TIMI frame count just after rotational atherectomy) ] less than 0. Absence of slow flow is defined as [(initial TIMI-frame count)x1.1 minus (TIMI frame count just after rotational atherectomy) ] not lower than 0. If >/=2 burrs are used for rotational atherectomy, slow flow will be evaluated only after the initial burr cross the lesion. Once initial burr crosses the lesion, slow flow will not be evaluated for this study after the second burr cross the lesion. If initial burr cannot cross the lesion and the second burr (typically smaller burr) cross the lesion, slow flow will be evaluated for this study after the second burr cross the lesion. If halfway rotational atherectomy is performed, slow flow will be evaluated just after halfway rotational atherectomy.
- Secondary Outcome Measures
Name Time Method Periprocedural myocardial infarction. Complications such as vessel perforation.