Health Condition 1: I779- Disorder of arteries and arterioles, unspecified
Conditions
Interventions
None listed
Sponsors
Dr Shuvanan Ray
Eligibility
Inclusion criteria
Inclusion criteria: Patients meeting with following criteria to be included in the study: 1. Patients aged 18 years and above of both gender. 2. Patients diagnosed with de novo coronary true bifurcation lesion. 3. Patients scheduled to undergo PCI procedure with Crush or Culotte technique utilizing sirolimus eluting stent. 4. Patients with medina classification of bifurcation lesions 1.1.1, 0.1.1 or 1.0.1. 5. Patients who are able to administer Dual Antiplatelet Therapy for a period of more than 1 year after PCI procedure. 6. Patients who are having proximal vessel size of ââ?°Â¥ 3mm and side branch vessel size of ââ?°Â¥ 2.5mm. 7. Patients with Calcified Plaque in the target vessel for PCI procedure can be included at Investigatorââ?¬•s discretion at study site. 8. Patient or Legally acceptable representative of patient willing to sign an Informed Consent Form indicating that they understand the purpose of and the procedures required for the trial and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: Patients meeting with following criteria to be excluded from the study: 1. Patients who have experienced acute myocardial infarction(STEMI) within 24 hours. 2. Patients with thrombus containing lesion. 3. Patients with triple vessel disease. 4. Patients with SYNTAX score > 23. 5. Patients who underwent prior coronary artery bypass grafting 6. Patients with known liver or kidney dysfunction (eGFR 7. Patients with left ventricular ejection fraction ââ?°Â¤30%. 8. Patients with life expectancy of less than 1 year. 9. Patients who are suspected of or known to have an intolerance to sirolimus. 10. Patients who are infected with COVID-19 at the time of enrolment as determined by the standard COVID-19 infection screening protocols followed by the clinical study site (hospital). 11. Presence of any other clinically significant disease or laboratory findings that in the Investigatorââ?¬•s opinion may affect the study outcomes. 12. Participation in another study concurrently or within 4 weeks prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the Target Vessel Failure before discharge and at 12 months post discharge.Timepoint: Before discharge (Baseline) and after 12 months of discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cardiac stress test evaluation at 9 months or 12 months post discharge 2. Angiographic evaluation results at 9 months or 12 months post discharge (if mandated by investigator) 3. Laboratory parameters (troponin and CK-MB) evaluation prior to and after PCI procedure(if mandated by investigator) 4. Target lesion failure 5. Rate of stent thrombosis 6. Blood transfusion required during PCI procedure 7. PCI procedural evaluation 8. Length of Hospital StayTimepoint: At 9 months and 12 months of discharge. | — |
Countries
India
Contacts
Public ContactDr Shuvanan Ray
Fortis Hospital, Anandapur, Kolkata
Outcome results
None listed