A post-marketing surveillance registry of the BioMatrix coronary stent in diabetic patients.

A postmarket surveillance registry of the BioMatrix drug eluting stent in diabetic patients. - EBMX(PMD)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2011/10/002088

Enrollment

1000

Registered

2011-10-24

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: By Biolimus A9 Drug Eluting Stent Intervention2: Percutaneous Transluminal Coronary Angioplasty: Biolimus A9 Eluting Stent in Diabetics.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients must be previously diagnosed with Type I or Type II diabetes with documented treatment with insulin or oral hypoglycemics by medical history. Undocumented or newly diagnosed diabetics must have either blood sugar fasting value of more than 115 mg per dl, post meal 140 mg per dl or glycosylated hemoglobin more than 7.3 percentage (if applicable) 2. Patients that need a treatment with a BioMatrix drug-eluting stent 3. Presence of one or more coronary artery stenoses in a native coronary artery, saphenous bypass graft, or radial vein graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents 3. No limitation on the number of treated lesions, and vessels, and lesion length.

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent 2. Patients needing additional stent NOT of the Biolimus A9-eluting stent type 3. Patients receiving next to the Biolimus A9-eluting stent also other coronary vascular interventions, for example dilation 4. Patients admitted for treatment of diabetic ketoacidosis 2 times in the past six months (Brittle Diabetics)

Design outcomes

Primary

Measure	Time frame
Major adverse cardiac events (MACE) within the study population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization.Timepoint: At 12 Months of enrollment.	—

Secondary

Measure	Time frame
Primary and secondary stent thrombosis (definite and probable according to Academic Research Consortium definitions;MACE (Major Adverse Cardiac Events) and TVR (Target Vessel Revascularization)Timepoint: at 1, 6, and 24 months of enrollment.	—

Countries

India

Contacts

Public ContactDr Hrishikesh Rangnekar

Biosensors International

h.rangnekar@biosensorsindia.com7387777465

Outcome results

None listed

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