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Clinical Trials/CTRI/2019/05/019297
CTRI/2019/05/019297
Recruiting
未知

Vascular Response in Patients with Diabetes Mellitus: An Optical Coherence Tomography Study of Ultrathin Strut Biodegradable Polymer-coated Sirolimus-eluting Stent

niversal Cardiovascular Research Foundation0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: I209- Angina pectoris, unspecified
Sponsor
niversal Cardiovascular Research Foundation
Status
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
niversal Cardiovascular Research Foundation

Eligibility Criteria

Inclusion Criteria

  • 1\. Patient must be at least 18 years of age
  • 2\. Patient with symptomatic coronary artery disease
  • 3\. Stable patients with diabetes mellitus
  • 4\. Only Supralimus Grace stent(s) is/are to be implanted into the coronary vasculature during the index procedure
  • 5\. Able to understand and sign the written informed consent form
  • 6\. Able and willing to follow the protocol requirements

Exclusion Criteria

  • 1\. ST\-segment elevation myocardial infarction within 7 days prior to the index procedure
  • 2\. Life expectancy \<12 months due to another medical condition
  • 3\. Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus or structurally related compounds
  • 4\. Creatinine level more than 2\.0 mg/dL or ESRD
  • 5\. Severe hepatic dysfunction (more than 3 times normal reference values)
  • 6\. Planned surgery procedure \<\=3 months post\-index procedure
  • 7\. Known allergy to cobalt\-chromium
  • 8\. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 3 months post index procedure
  • 9\. No suitable anatomy for OCT scan in the opinion of investigator

Outcomes

Primary Outcomes

Not specified

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