To study safety and efficacy of an established marketed coronary stent, BioMatrix flex in coronary artery disease.

A prospective, single arm Physician Initiated Trial (PIT) to assess safety and efficacy of Biolimus A9â??Eluting Stent (BES) â?? BioMatrix flex: All-Comers including complex case sub-group

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/12/003182

Enrollment

150

Registered

2012-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Coronary Artery Occlusion

Interventions

Intervention1: Percutaneous Transluminal Coronary Angioplasty: Biolimus A9 Eluting Stent in general population. Drug is secreted till 6 to 9 months of deployment of stent. Dose of the drug is 15.6 mic

Eligibility

Inclusion criteria

Inclusion criteria: 1. Eligible and willing patient for percutaneous transluminal coronary angioplasty (PTCA) requiring stenting with Bio-Limus A9-Eluting Coronary Stent. 2. Informed and consented. 3. Patient agreeing to comply with protocol specified follow-up evaluations.

Exclusion criteria

Exclusion criteria: 1. Participating in investigational drug/device Trial that has not completed primary endpoint or interferes with Trial endpoints 2. Patients stented/deployed with additional stent which is not BES. 3. Known allergy to aspirin, clopidogrel, heparin, stainless steel, sirolimus, biolimus, contrast material 4. Renal Dysfunction ( Creatinine > 3mg% ) 5. Pregnancy 6. Elective surgery within 6 months of stent implantation

Design outcomes

Primary

Measure	Time frame
Study device oriented major adverse cardiac events (MACE) defined as Composite of cardiac death, myocardial infarction (Q-wave and Non-Qwave), or justified target vessel revascularization.Timepoint: At 9 months	—

Secondary

Measure	Time frame
1. MACE (Composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave), or justified target vessel revascularization) ; 2. Stent thrombosis rate (As per Academic Research Consortium)Timepoint: At 30 days, 9 and 12 Months.	—

Countries

India

Contacts

Public ContactTushar Mhetre

Seth Nandlal Dhoot Hospital

drvilas2007@rediffmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026