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Clinical Trials/CTRI/2024/02/062438
CTRI/2024/02/062438
Not yet recruiting
Phase 4

A prospective, single-arm, multi-centre study to evaluate the safety and performance of MeRes100™ Sirolimus Eluting BioResorbable Vascular Scaffold System by clinical and imaging outcomes in patients with coronary artery disease - RESET

Meril Diagnostics Private Limited0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Sponsor
Meril Diagnostics Private Limited
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Pms

Investigators

Sponsor
Meril Diagnostics Private Limited

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients aged \=18 years.
  • •2\. Patients with de novo coronary artery lesions with reference vessel diameter of \=2\.75 mm to \=4\.0 mm.
  • •3\. Patient has given written informed consent for participation prior to enrolment.
  • •4\. Patient is willing to undergo all study procedures and follow\-up requirements.

Exclusion Criteria

  • •1\. Hypersensitivity or allergy to aspirin, heparin, clopidogrel, bivalirudin,ticlopidine, prasugrel, ticagrelor and drug such as Sirolimuds or similar drugs or any analogue or derivative, poly\-Llactide, poly\-DL\-lactide, platinum, or with any contrast media Patient in whom anti\-platelet and/or anti\-coagulant therapy are contraindicated
  • •2\. Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon
  • •3\. Pregnant or lactating female
  • •4\. Left main coronary artery disease
  • •5\. Aorta ostial lesion and Lesion in a bypass graft
  • •6\. Any PCI less than 6 months prior to the index procedure
  • •7\. Previous CABG in the target vessel
  • •8\. And other exclusions as specified in the protocol

Outcomes

Primary Outcomes

Not specified

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