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Follow-up assessment of long length GenX Sync stent in Coronary Artery Disease patients

GEL Registry: Study of GenXSync Sirolimus Eluting Stent in Real World Patients with Long and Very Long Lesions. - GEL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/07/004783
Enrollment
30
Registered
2014-07-30
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 Disease- Requiring to undergo PCI as treatment

Interventions

Intervention1: GenX Sync : Sirolimus Eluting Coronary Stent Intervention2: Drug Eluting Stent: Sirolimus Eluting Coronary Stent Control Intervention1: NIL: NIL

Sponsors

MIV Therapeutics India PvtLtd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Treated or Treatment feasible with Percutaneous coronary intervention using one or multiple stents with lengths of 40 mm or more. 2. Target lesion stenosis >70% (visual estimate). 3. Reference vessel > 2.5 - 4.0 by visual estimate. 4. No limitation to the number of treated lesions, number of vessels or lesion length. 5. Willing to give informed written consent. 6. Willing for 6 month Angiographic follow-up.

Exclusion criteria

Exclusion criteria: 1. Platelet count 700,000 cells/mm3, a WBC of documented or suspected liver disease (including laboratory evidence of hepatitis). 2. Recipient of heart transplant; 3. Known allergies to aspirin, clopidogrel bisulphate (Plavix®), ticlopidine (Ticlid®), heparin or stainless steel. 4. Presence of Chronic Renal Failure (creatinine > 2.5 mg/dl) or advanced malignancy. 5. Scheduled for major non-cardiac surgery within six months of PCI. 6. Inability to provide informed consent

Design outcomes

Primary

MeasureTime frame
Major adverse cardiac events (MACE) defined as Death MI CABG or TLR (repeat PCI or CABG) at 1 month & 6 months Late Lumen Loss at 6 to 8 months assessed by angiography or IVUS study. Timepoint: 6 to 9 months—

Secondary

MeasureTime frame
â?¢ Procedural endpoint o Device success rate [%]Timepoint: 6 to 9 months;â?¢ Target Vessel Failure (TVF) at 1, 6, and 12 month clinical follow-up defined as: cardiac death, myocardial infarction, and target lesion revascularization (repeat PTCA or coronary bypass surgery for recurrent symptoms related target-lesion re-narrowing).Timepoint: 6-9 months;Clinically driven target lesion revascularization (TLR) at 1, 6, & 12-month.Timepoint: 6-9 months—

Countries

India

Contacts

Public ContactMr Mukund Barde

Ruby Hall Clinic

shirish.hiremath2011@gmail.com020-66455376

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 2, 2026