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.
Investigators
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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