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

Phase 4

• Conditions: Health Condition 1: null- Coronary Artery Disease- Requiring to undergo PCI as treatment

• Registration Number: CTRI/2014/07/004783
• Lead Sponsor: MIV Therapeutics India PvtLtd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 30

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 < mm in diameter

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

1. Platelet count < 100,000 cells/mm3 or >700,000

cells/mm3, a WBC of < 3,000 cells/mm3, or

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified