JPRN-jRCT2042230026
Recruiting
未知
A multicenter, single-arm study to evaluate the safety and feasibility of PMA System for chronic total occlusion of coronary arteries
asu Kenya0 sites20 target enrollmentMay 26, 2023
ConditionsIschemic Heart Disease
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Ischemic Heart Disease
- Sponsor
- asu Kenya
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Submitted written consent to participate in the clinical trial of his/her own free will
- •2\. Eighteen years of age or older and under 80 years of age at the time of consent
- •3\. Has an eligible CTO
- •4\. CTO is not located at the coronary ostium
- •5\. The distal true lumen can be clearly visualized either by antegrade or contralateral injection
- •6\. Distal lumen diameter of CTO is 1\.0 mm or more
- •7\. Has one of the following CTOs
- •\-One lesion (CTO) in one branch
- •\-Only 1 lesion can be treated with the investigational procedure if more than 2 CTOs
- •8\. Meets PCI eligibility criteria and allows CABG and coronary stenting
Exclusion Criteria
- •1\. Heart rate not in 30 \- 145 bpm range before PMA
- •2\. Permanent pacemaker implanted
- •3\. The target lesion of PMA is in the stent
- •4\. No more than 8 weeks after coronary stenting, regardless of target CTO branch
- •5\. LVEF \< 30%
- •6\. Inability to take antiplatelet or anticoagulant therapy
- •7\. Allergic to iodinated contrast media
- •8\. Abnormal CK level or myocardial infarction in the past 72 hours
- •9\. Has lesions in the deep veins of the lower extremities
- •10\. Has a bleeding tendency or coagulopathy
Outcomes
Primary Outcomes
Not specified
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