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Clinical Trials/CTRI/2018/04/013445
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Command Hospital Air Force Bangalore

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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