Evaluation of a New Nanotechnology Based Drug-Eluting Stent for Opening of Narrowed Arteries of the Heart

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00428662
• Date of registration: 29/01/2007
• Primary sponsor: All India Institute of Medical Sciences, New Delhi
• Public title: Evaluation of a New Nanotechnology Based Drug-Eluting Stent for Opening of Narrowed Arteries of the Heart
• Scientific title: Clinical and Angiographic Evaluation of Paclitaxel Eluting, Non-Polymeric, Nanoporous Carbon-Carbon Coated, Cobalt-Chromium Stent
• Date of first enrolment: January 2007
• Target sample size: 200
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00428662
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

India

Contacts

• Name: Balram Bhargava, MD, DM

• Name: Balram Bhargava, MD, DM
• Affiliation: All India Institute of Medical Sciences, New Delhi

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or non-pregnant female 2: 18 years of age (note: females of child bearing
potential must have a negative pregnancy test within 7 days of treatment and must use
effective pregnancy avoidance until the 6 month angiogram is completed)

2. Have chest pain consistent with angina pectoris or a history of documented myocardial
infarction or documented silent ischemia

3. Treatment of a native vessel de novo coronary lesion (only 1 single study
lesion/patient)

4. Target vesseI2.5mm-4.0mm in diameter (visual estimate)

5. Target lesion length::: 12mm (visual estimate)

6. Target lesion stenosis> 50% and < 100% (visual estimate)

7. At least TIMI grade II coronary flow

8. Acceptable candidate for CABG surgery

9. Patient is willing to come back for a follow-up evaluations including repeat cardiac
catheterization 5-7 months after treatment

10. Patient must provide written informed consent prior to the index procedure using a
form that is approved by the local Ethics Committee

Exclusion Criteria:

1. Patient has experienced an acute myocardial infarction (Q wave or non-Q wave) within
72 hours prior to the index procedure with CK enzymes 2: 2x the local laboratory
upper limit of normal, with the presence of CK- MB levels elevated above the local
laboratory upper limit of normal;

2. Unprotected left main coronary disease with> 50% stenosis;

3. Significant (> 50%) stenosis proximal or distal to the target lesion that might
require revascularization or impede runoff;

4. Ostial location of the target lesion;

5. Angiographic evidence of thrombus within the target lesion;

6. Severely calcified'lesion which cannot be successfully predilated;

7. Documented L VEF < 25%, or clinically significant congestive cardiac failure;

8. Totally occluded vessel;

9. Impaired renal function (creatinine> 0.27mmol/L) at the time of treatment;

10. Pretreatment with devices other than balloon angioplasty;

11. Excessive tortuosity proximal to the lesion which makes stent delivery and deployment
uncertain;

12. Target lesion involves a bifurcation including a diseased side branch> 2.5mm in
diameter that would require treatment;

13. Prior stenting within 5mm of the target lesion;

14. Patient is a recipient of a heart transplant;

15. Patient has a life expectancy < 12 months;

16. Known allergies to clopidogrel bisulfate (Plavix@), ticlopidine (Ticlid@), Cobalt
Chromium alloy and Paclitaxol that cannot be medically managed;

17. In the investigator's opinion, any significant medical condition which may interfere
with the patient's optimal participation in this study;

18. Currently participating in an investigational drug or device study that has not
completed the primary endpoint;

19. Intervention of another coronary lesion has occurred within 30 days before or is
planned within 30 days after the index procedure.

20. In the investigator's opinion, the lesion is not suitable for stenting



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Stenosis

Intervention(s)

Device: drug eluting nonpolymeric nanoporous stent

Primary Outcome(s)

In-stent late loss as compared historically to other DES, within the stented segment post-procedure and at 6-9-month follow-up

Secondary Outcome(s)

Major adverse cardiac events

Stent thrombosis rate (acute, subacute, or chornic)

Secondary ID(s)

0101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors