NCT00936780

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

2.7 years

First QC Date

July 8, 2009

Last Update Submit

August 22, 2012

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseRestenosisStent thrombosisCoronary stentsAngioplastyDrug Eluting Stents (DES)

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Events (MACE)

    30 days and 9 month

Secondary Outcomes (1)

  • ANGIOGRAPHIC

    12 months

Study Arms (1)

Infinnium-Core™ Paclitaxel eluting Coronary Stent

EXPERIMENTAL
Device: Infinnium-Core™ Paclitaxel eluting Coronary Stent

Interventions

Infinnium-Core™ Paclitaxel eluting Coronary StentDEVICE

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.

Also known as: Drug Eluting Stent (DES)
Infinnium-Core™ Paclitaxel eluting Coronary Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Eligible for percutaneous coronary intervention (PCI).
  • Acceptable candidate for CABG.
  • 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.

You may not qualify if:

  • The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
  • The target lesion must be ≤ 37 mm in length by visual estimate.
  • The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm.
  • 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.
  • Female of childbearing potential.
  • Documented left ventricular ejection fraction (LVEF) ≤ 25%.
  • Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure.
  • 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).
  • A platelet count \<100,000 cells/mm3 or \> 700,000 cells/mm3 or a WBC \< 3,000 cells/mm3.
  • Acute or chronic renal dysfunction (creatinine \> 2.0 mg/dl or \> 150 µmol/L).
  • Target vessel has evidence of thrombus.
  • Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment.
  • Previous bare metal stenting (less than 1 year) anywhere within the target vessel.
  • Previous drug-eluting stenting anywhere within any epicardial vessel
  • 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 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bankers Heart Institute

Vadodara, Gujarat, 390 015, India

Location

Baroda Heart Institute & Research Center

Vadodara, Gujarat, 390007, India

Location

CHL Apollo Hospitals,

Indore, Madhya Pradesh, 452008, India

Location

CHL Apollo Hospitals

Indore, Madhya Pradesh, 452008, India

Location

Government Medical College & Super Speciality Hospital

Nagpur, Maharashtra, 440003, India

Location

Arneja Heart Institute

Nagpur, Maharashtra, 440010, India

Location

Sri Ramakrishna Heart Foundation & Research Centre

Coimbatore, Tamil Nadu, 641 044, India

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 10, 2009

Study Start

July 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

IN(7)