A Study to Evaluate the safety and performance of dedicated bifurcation stent in patients with de novo coronary bifurcation lesions.

Dedicated Branch Stent vs Conventional Stent in Bifurcation Coronary stenosis -A medium term followup

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062723

Enrollment

Registered

2024-02-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Bifurcation stent: A single stent is placed across the bifurcation. The proximal stent is optimised (POT) with a non compliant balloon sized to the proximal main vessel size. Rewiring o

Eligibility

Inclusion criteria

Inclusion criteria: 1.The patientmustbegreaterthan euqal 18 years of age.2.True coronary bifurcation greaterthan equal to 50 percentage diameter stenosis in both the main and side branches, belonging to the Medina classes 1,1,1 or 1,0,1 or 0,1,1.3.Patients with de novo bifurcation lesions in native coronary arteries with reference diameter ranging from 2.5 mm to 3.5 mm in the side branch and 2.5 mm to 4.0 mm in main branch4.Patient must agree not to participate in any other clinical trial for a period of two years following the index procedure. 5.The patient is willing to comply with protocol specified follow-up evaluations.6.Patient or his or her legally authorized representative if applicable agrees to provide written informed consent as approved by respective Ethics Committee and applicable regulatory authorities.

Exclusion criteria

Exclusion criteria: 1.Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drug such as Sirolimus Rapamycin or similar drugs or any analogue or derivative, cobalt, chromium, nickel, molybdenum, tungsten or any contrast media.2.Patients in whom anti-platelet and or anticoagulant therapy are contraindicated. 3.Angiographic evidence of thrombus.4.Direct stenting of the left main bifurcation 5.Impaired runoff in the treatment vessel with diffuse distal disease.6.A significant greaterthan 50 percentage stenosis proximal to distal to the target lesion. 7.Ejection fraction lessthan 30 percentage 8.Patient requiring anticipated rotational atherectomy as per the Investigators judgement. 9.Highly calcified lesions in which full stent dilatation may not be possible.10.Patients with totally occluded vessel.11.Target lesion has excessive tortuosity unsuitable for stent delivery and deployment. 12.Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon. 13.Patient has undergone heart transplant or any other organ transplant or planned to undergo any organ transplant. 14.Pregnant or nursing patients or those who plan pregnancy during study period 15.Any condition, which in the Investigators opinion would preclude safe participation of patient in the study

Design outcomes

Primary

Measure	Time frame
?Major Adverse Cardiac Events (MACE) [Time Frame: 1 Year] Major adverse cardiac events are the composite of cardiac death, Target vessel myocardial infarction (TV-MI) and clinically driven target lesion revascularization (CD-TLR) [1]Timepoint: ONE YEAR	—

Secondary

Measure	Time frame
Cardiac Death:Timepoint: 30 days , six months , one year ,Two years	—

Countries

India

Contacts

Public ContactYathish kumar

Meril Life Sciences Pvt Ltd

yathishkumar555@gmail.com8019851312

Outcome results