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Coronary Artery DiseaseNCT01121744

Supralimus-Core™ Pharmacokinetic (PK) Study

A study testing Supralimus-Core™ Sirolimus eluting Coronary Stent in people with Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 4 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Supralimus-Core™ Sirolimus eluting Coronary Stent
Type of treatment
Medical device
How many people
20 participants
Where
4 sitesIndia
Study dates
Apr 2010to Jan 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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.
  • The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
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  • 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.

Who cannot join

  • 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)
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  • 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.)
  • Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off
  • Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
  • Target lesion is located in or supplied by an arterial or venous bypass graft
  • Ostial target lesion
  • Patient is currently participating in an investigational drug or device study, including its follow-up period
  • Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind
  • Within 48 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.
  • CVA within previous 6 months
  • Unprotected Left Main (LM) coronary artery disease (stenosis >50%)
  • 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
  • Planned surgery within 48 days after the index procedure
  • Life expectancy less than 1 year
  • Any contraindication to blood sampling

Trial locations and contacts

4 sites in 1 country.

India4 sites

  • Life Care Institute of Medical Science & research

    Ahmedabad, Gujarat, 380014

  • Shree B. D. Mahavir Heart Institute

    Surat, Gujarat, 395001

  • Baroda Heart Institute & Research Center

    Vadodara, Gujarat, 390007

  • Bankers Heart Institute

    Vadodara, Gujarat, 390015

Other trials in India

About this study

Official title: Supralimus-Core™ Pharmacokinetic (PK) Study: Evaluation of Pharmacokinetic (PK) and Safety of the Supralimus-Core™ Sirolimus Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

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.

Read the detailed description

This is a multi-centric, interventional, non-randomized, open label, Uncontrolled, single group assignment, Pharmacokinetics study. Approximately 20 patients will be enrolled in the study. Patients will be followed for 48 days post-procedure.

Being tested
Supralimus-Core™ Sirolimus eluting Coronary Stent
Keywords
Coronary Artery Disease, Drug Eluting Stents (DES), Pharmacokinetic (PK)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supralimus-Core™ Sirolimus eluting Coronary StentDevice

    Also called Drug Eluting Stent (DES)

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax, Tmax, AUC24h, AUClast, AUC∞, λz, t½term, CL

    Measured: Up to 48 days

Secondary outcomes (1)

  1. Major Adverse Cardiac Event (MACE)

    Measured: Up to 48 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionNov 2010
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01121744
Sponsor's protocol ID
SC001:V.1.0:Dated 12/12/2008.
Status last verified
Jul 2012
First submitted
10 May 2010
Last updated
4 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22664810

Questions about this trial

What is this clinical trial studying?

A study testing Supralimus-Core™ Sirolimus eluting Coronary Stent in people with Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 4 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax, Tmax, AUC24h, AUClast, AUC∞, λz, t½term, CL (time frame: Up to 48 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01121744, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2012.

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