Comparative study of stenting techniques for coronary bifurcation lesions in patients undergoing PCI.

Not Applicable

• Conditions: Health Condition 1: I779- Disorder of arteries and arterioles, unspecified

• Registration Number: CTRI/2021/06/034102
• Lead Sponsor: Dr Shuvanan Ray

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 � 3mm and side branch vessel size of �

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

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 <60)

7. Patients with left ventricular ejection fraction �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.

Study & Design

• Study Type: Observational
• Study Design: Not specified