Health Condition 1: E115- Type 2 diabetes mellitus with circulatory complications
Conditions
Interventions
Intervention1: Supraflex Cruz Sirolimus-eluting coronary stent system: Supraflex Cruz is the latest generation DES, approved by DCGI and has received CE mark approval in June-2019 in the European Unio
Sponsors
Academics and Research Department Batra Hospital Medical Research Centre
JSS Medical Research Asia Pacific Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age greater or equal to 18 years 2.Patient with diabetes mellitus (Type 1 or Type 2) 3.Angiographically confirmed multivessel CAD [critical (greater or equal to 70 percent) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA]. The population will consist of approximately 85percent patients with triple vessel disease 4.Angiographic characteristics amenable to PCI as decided by the heart team 5.Indication for revascularization based upon symptoms of angina or angina equivalents andor objective evidence of myocardial ischemia 6.Willing to comply with all follow-up required study visits 7.Signed informed consent
Exclusion criteria
Exclusion criteria: 1.Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment. 2.Prior CABG surgery. 3.Prior PCI with stent implantation within 6 months. 4.Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score greater 1. 5.Prior history of significant bleeding (within the previous 6 months) that might preclude use of dual antiplatelet therapy. 6.In-stent restenosis of a target vessel. 7.Two or more chronic total occlusions in major coronary territories that are targeted for revascularization. 8.Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization. 9.Contraindication to PCI because of a coexisting clinical condition 10.Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor or prasugrel. 11.Extra-cardiac illness that is expected to limit survival to less than 5 years. 12.Women who are pregnant, nursing, or who plans to become pregnant while the study. 13.Concurrent enrollment in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare clinical outcomes of percutaneous coronary intervention (PCI) with the ultrathin Supraflex Cruz vs. Xience family when combined with contemporary optimal medical therapy (OMT) in patients with diabetes mellitus and multi vessel disease with respect to target lesion failure (TLF)Timepoint: At 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate whether the pooled cohort from both arms of the study (Supraflex Cruz and Xience family) provides similar clinical outcomes (composite of all-cause mortality, nonfatal myocardial infarction (MI), or stroke) to the coronary artery bypass graft surgery based on performance goal derived from the CABG arm of the FREEDOM trial (historical control)Timepoint: up to 5 years. | — |
Countries
India
Contacts
Public ContactNagma Khan
Batra Hospital and Medical Research Centre
Outcome results
None listed