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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00428662
Recruitment Status : Unknown
Verified January 2007 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
First Posted : January 30, 2007
Last Update Posted : January 30, 2007
Information provided by:
All India Institute of Medical Sciences, New Delhi

Brief Summary:
Coronary artery disease (CAD) is the largest cause of death and disability in the world. Besides medicines, the principle treatment of this condition requires opening of the narrowed arteries, responsible for angina and other symptoms of the disease, by angioplasty or surgery. Introduction of metal scaffolds called 'stents' in the past few decades revolutionised the angioplasty technique, and has made it the most popular treatment today for CAD. However these stents are prone to becomin narrow and obstructed after implanataion, causing symptoms and non-fatal heart attacks in some patients. Introduction of stents that slowly release drugs locally to minimize this process, called 'drug-eluting stents'(DES)he past few years has been one of the biggest breakthroughs in the field of cardiology. However ven the current available DES are still prone to narrowing in high-risk patients, like those with diabetes, and also have a higher chance for sudden blockage by a blood clot even many years later after insertion. Thus it is important to develop technology for more efficacious and safer DES.This includes safer drugs, better stent design and delivery, and more inert platforms for drug release We hypothesise that a new stent made with nanoporous particle with better polymer for drug release will prove to be safer and more efficacious alternative to currently available DES.

Condition or disease Intervention/treatment Phase
Coronary Stenosis Device: drug eluting nonpolymeric nanoporous stent Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Angiographic Evaluation of Paclitaxel Eluting, Non-Polymeric, Nanoporous Carbon-Carbon Coated, Cobalt-Chromium Stent
Study Start Date : January 2007
Study Completion Date : October 2007

Primary Outcome Measures :
  1. 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 Measures :
  1. Major adverse cardiac events
  2. Stent thrombosis rate (acute, subacute, or chornic)

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00428662

Contact: Balram Bhargava, MD, DM 91-11-26588663

All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Principal Investigator: Balram Bhargava, MD, DM         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Principal Investigator: Balram Bhargava, MD, DM All India Institute of Medical Sciences, New Delhi

Publications: Identifier: NCT00428662     History of Changes
Other Study ID Numbers: 0101
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: January 30, 2007
Last Verified: January 2007

Keywords provided by All India Institute of Medical Sciences, New Delhi:
coronary stenting
drug eluting stents

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action