CTRI/2018/04/013445
Not yet recruiting
未知
A prospective, observational and clinical study to evaluate sub optimal stent deployment during coronary stenting of complex coronary lesions using optical coherence tomography
Command Hospital Air Force Bangalore0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Complex coronary artery disease
- Sponsor
- Command Hospital Air Force Bangalore
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects meeting ALL the below mentioned criteria would be included in the study:
- •1\. Age 18\-90 years.
- •2\. Eligible for Coronary Revascularisation.
- •3\. Diagnosis of CAD (either or both)
- •a. Angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, Ill, IV).
- •b. Diagnosis of ACS (STEMI as defined by Universal definition of myocardial infarction after window period, NSTEACS as defined by E Braunwald)
- •4\. Target reference vessel diameter of lesions \> 2\.5mm and \< 4\.0mm in diameter (angiographic estimate).
- •5\. Target lesion stenosis for lesions is \> 50% and \< 100% (visual estimate).
- •6\. At least TIMI I coronary flow.
- •7\. Complex lesion as defined as any one or more of the following
Exclusion Criteria
- •1\. Any history of bleeding diathesis or coagulopathy
- •2\. ST\-elevation acute myocardial infarction within window period
- •3\. Known hypersensitive or contra\-indicated to contrast agent, heparin, aspirin, clopidogrel , ticagrelor or prasugrel (that cannot be managed medically).
- •4\. Azotemic patients with eGFR \< 60 ml/min
- •5\. Severe hemodynamic instability or shock
- •6\. Bacteremia or sepsis
- •7\. Diagnosis of coronary artery spasm/Prinzmetalâ??s angina
- •8\. Pregnant or nursing
- •9\. Unprotected ostial left main or ostial right coronary artery disease (stenosis \>50%).
- •10\. Significant ( \> 50%) stenosis proximal or distal to the target lesionS.
Outcomes
Primary Outcomes
Not specified
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