Infinnium-Core™ Registry for the Treatment of Patients With De Novo Coronary Lesions

This study has been terminated.
(market demand from paclitaxel to sirolimus drug-eluting stent)
Sponsor:
Information provided by (Responsible Party):
Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT00936780
First received: July 8, 2009
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

The primary objective of Infinnium-Core™ Registry is to assess the safety and efficacy of the Infinnium-Core™ Paclitaxel Eluting Coronary Stent System in de novo Coronary Lesions.


Condition Intervention Phase
Coronary Artery Disease
Device: Infinnium-Core™ Paclitaxel eluting Coronary Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the Infinnium-Core™ Paclitaxel-Eluting Coronary Stent System for the Treatment of Patients With De Novo Coronary Lesions

Resource links provided by NLM:


Further study details as provided by Sahajanand Medical Technologies Pvt. Ltd.:

Primary Outcome Measures:
  • Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days and 9 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ANGIOGRAPHIC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    In Angiographic outcome measures the Minimal lumen diameter (MLD), % diameter stenosis, In-Stent and In-segment late loss, Proximal late loss, Distal late loss and Binary restenosis rate


Enrollment: 67
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infinnium-Core™ Paclitaxel eluting Coronary Stent Device: Infinnium-Core™ Paclitaxel eluting Coronary Stent
Infinnium-Core™ Coronary Stent System consisting of the Coronnium® coronary stent (CE approved) having Biodegradable Polymeric Matrix on a Co-Cr alloy Platform. Drug concentration is 1.36 µg/mm2.
Other Name: Drug Eluting Stent (DES)

Detailed Description:

Infinnium-Core™ Registry is a multi-centric, prospective study. Approximately 150 patients will be enrolled in the study. Patients will be followed for two years post-procedure.

Data analysis will include all statistically pre assigned 20% patients and all patients who have repeat angiography due to complication. The diabetic patients will be specified as a high risk subset in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Eligible for percutaneous coronary intervention (PCI).
  3. Acceptable candidate for CABG.
  4. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1,2,3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia.
  5. The target lesion is a single de novo coronary artery lesion with ≥ 50% and < 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent.
  6. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
  7. The target lesion must be ≤ 37 mm in length by visual estimate.
  8. The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm.
  9. Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as notified / approved by the Institutional Review Board/Ethics Committee of the clinical site.

Exclusion Criteria:

  1. Female of childbearing potential.
  2. Documented left ventricular ejection fraction (LVEF) ≤ 25%.
  3. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure.
  4. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, paclitaxel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated).
  5. A platelet count <100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3,000 cells/mm3.
  6. Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/L).
  7. Target vessel has evidence of thrombus.
  8. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment.
  9. Previous bare metal stenting (less than 1 year) anywhere within the target vessel.
  10. Previous drug-eluting stenting anywhere within any epicardial vessel
  11. The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g., but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
  12. Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off.
  13. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated.
  14. Target lesion is located in or supplied by an arterial or venous bypass graft.
  15. Ostial target lesion.
  16. Patient is currently participating in an investigational drug or device study, including its follow-up period.
  17. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind.
  18. Within 60 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.
  19. CVA within previous 6 months.
  20. Unprotected Left Main (LM) coronary artery disease (stenosis > 50%).
  21. In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
  22. Planned surgery within 6 months after the index procedure.
  23. Life expectancy less than 1 year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936780

Locations
India
Bankers Heart Institute
Vadodara, Gujarat, India, 390 015
Baroda Heart Institute & Research Center
Vadodara, Gujarat, India, 390007
CHL Apollo Hospitals,
Indore., Madhya Pradesh., India, 452008
CHL Apollo Hospitals
Indore, Madhya Pradesh, India, 452008
Arneja Heart Institute
Nagpur, Maharashtra, India, 440010
Government Medical College & Super Speciality Hospital
Nagpur, Maharashtra, India, 440003
Sri Ramakrishna Heart Foundation & Research Centre
Coimbatore, Tamilnadu, India, 641 044
Sponsors and Collaborators
Sahajanand Medical Technologies Pvt. Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT00936780     History of Changes
Other Study ID Numbers: IC001: V1.1
Study First Received: July 8, 2009
Last Updated: August 22, 2012
Health Authority: India: Drugs Controller General of India

Keywords provided by Sahajanand Medical Technologies Pvt. Ltd.:
Coronary Artery Disease
Restenosis
Stent thrombosis
Coronary stents
Angioplasty
Drug Eluting Stents (DES)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014