NCT01121744

Brief Summary

The primary objective of this study is to evaluate the pharmacokinetic (PK) and safety associated with Supralimus-Core™ Sirolimus Eluting Coronary Stent system in the treatment of single de novo lesions in native coronary arteries between 2.5 to 3.5 mm in diameter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

4 active sites

Status
completed

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

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

7 months

First QC Date

May 10, 2010

Last Update Submit

July 3, 2012

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseDrug Eluting Stents (DES)Pharmacokinetic (PK)

Outcome Measures

Primary Outcomes (1)

  • Cmax, Tmax, AUC24h, AUClast, AUC∞, λz, t½term, CL

    Up to 48 days

Secondary Outcomes (1)

  • Major Adverse Cardiac Event (MACE)

    Up to 48 days

Interventions

Supralimus-Core™ Sirolimus eluting Coronary StentDEVICE

Supralimus-Core™ Coronary Stent System consisting of the Coronnium® coronary stent (CE approved) having Biodegradable Polymeric Matrix on a Co-Cr alloy Platform. Sirolimus Drug concentration is 1.4 µg/mm2.

Also known as: Drug Eluting Stent (DES)

Eligibility Criteria

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

You may not 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.
  • 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 ≤ 34 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, sirolimus, 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 \>2.0mg/dl or \>150µmol/L)
  • Target vessel has evidence of thrombus
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Life Care Institute of Medical Science & research

Ahmedabad, Gujarat, 380014, India

Location

Shree B. D. Mahavir Heart Institute

Surat, Gujarat, 395001, India

Location

Baroda Heart Institute & Research Center

Vadodara, Gujarat, 390007, India

Location

Bankers Heart Institute

Vadodara, Gujarat, 390015, India

Location

Related Publications (1)

  • Thakkar AS, Abhyankar AD, Dani SI, Banker DN, Singh PI, Parmar SA, Mehta AA. Systemic exposure of sirolimus after coronary stent implantation in patients with de novo coronary lesions: Supralimus-Core(R) pharmacokinetic study. Indian Heart J. 2012 May-Jun;64(3):273-9. doi: 10.1016/S0019-4832(12)60086-8.

    PMID: 22664810RESULT

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
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

April 1, 2010

Primary Completion

November 1, 2010

Study Completion

January 1, 2011

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

IN(4)