Coronary Artery DiseaseMaximusNCT00811616
A Safety and Efficacy of Supralimus™ Core™ Sirolimus Eluting Stent at MAX DDHV Institute
A study testing Supralimus-Core™ and Supralimus™ Core™ Sirolimus eluting stent in people with Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 1 site in India.
Trial summary
OBJECTIVES: The primary objective of this study is to assess the safety and efficacy of the Supralimus - Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease. STUDY DESIGN: This is a single centre, prospective study. Approximately 105 patients were enrolled in the study. 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™ and Supralimus™ Core™ Sirolimus eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2006to Mar 2008
- 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
- The patient must be >= 18 years of age;
- Symptomatic ischemic heart disease (CCS class 1 -4 , Braunwald class IB, IC, IIB, IIC, IIIB,IIIC) and/or objective evidence of myocardial ischemia;
- Vessel size of >= 2.5 and <= 3.5mm.
- Target lesions which can be covered by stent in a manner lesion stent ratio of at least 1.5.
- Acceptable candidate for coronary artery bypass surgery (CABG);
- Target lesion stenosis is >50% and <100% (TIMI flow I) (visual estimate);
- The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB).
Who cannot join
- Women of childbearing potential;
- Impaired renal function (creatinine > 2.0 mg/dl or 177 µmol/l);
- Any patient who has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis);
- Recipient of heart transplant;
- Restenotic or lesion in graft.
- Patient with a life expectancy less than 12 months;
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- Known allergies to aspirin, clopidogrel bisulphate (Plavix), ticlopidine (Ticlid), heparin or stainless steel;
- Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
- Currently participating in an investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow-up.
- Angiographic Exclusion criteria:
- Unprotected left main coronary artery disease with >=50% stenosis;
- Angiographic evidence of thrombus (thrombus larger than half the diameter of the vessel and/or requiring other interventions such as angiojet, exciser, thrombolysis, etc.);
- Ejection fraction <= 30%;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety And Efficacy Evaluation of Sirolimus Eluting Supralimus-Core™ Stent at MAX DDHV Institute in the Treatment of de Novo Native Coronary Artery Lesions
OBJECTIVES:
The primary objective of this study is to assess the safety and efficacy of the Supralimus - Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease.
Read more
STUDY DESIGN:
This is a single centre, prospective study. Approximately 105 patients were enrolled in the study. Patients were followed for twelve months post-procedure. All patients were to have a repeat angiography at 8 months.
STUDY POPULATION:
The study population consisted of approximately 105 patients with de novo native vessel obstructive coronary artery disease with no specific criteria. Patients from the daily practice were included. Patients had to meet all eligibility criteria for inclusion into the study.
ENDPOINTS:
The primary safety endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at 30 days.
The primary efficacy endpoint is the in-stent binary restenosis rate at 8-month follow-up determined by off-line Quantitative Coronary Angiography.
The following secondary efficacy endpoints were assessed
- Angiographic success
- Procedure success
- Quantitative Coronary Angiography derived vessel parameters in-stent and 5 mm proximal and 5 mm distal from the edge of the stent: acute gain, MLD, % DS, late loss, mean diameter. In-stent pre-, post and at 8-month follow-up.
- Clinically justified Target Lesion Revascularization (TLR) at 12 months
The following secondary safety endpoints were assessed:
- MACE until 12 months
- Device related SAEs until 12 months
- Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after 30 days until 12 months)
- Conditions
- Coronary Artery Disease
- Being tested
- Supralimus-Core™, Supralimus™ Core™ Sirolimus eluting stent
- Keywords
- Coronary artery disease, Supralimus-Core™, de novo native coronary artery lesion
- 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™Device
Sirolimus Eluting Cobalt Chromium based coronary stent system
Supralimus™ Core™ Sirolimus eluting stentDevice
Supralimus™ Core™ Sirolimus eluting stent intended to treat coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| Supralimus™ Core™ Sirolimus eluting stent | Experimental | Supralimus™ Core™ Sirolimus eluting stent manufactured by Sahajanand Medical Technologies Limited intended to treat coronary artery disease. Receives: Device: Supralimus-Core™; Device: Supralimus™ Core™ Sirolimus eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint: Major Adverse Cardiac Events (MACE)
Measured: 30 days
Primary efficacy endpoint: In-stent binary restenosis rate determined by off-line Quantitative Coronary Angiography.
Measured: 8 Month
Secondary outcomes (2)
Secondary safety endpoints: - MACE until 12 months, Device related SAEs until 12 months, Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after 30 days until 12 months)
Measured: 12 months
Secondary efficacy endpoints: Angiographic, Procedure success; acute gain, MLD, % DS, LL, mean diameter; In-stent pre-,post,8-month follow-up; Clinically justified TLR at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startJul 2006
- Primary completionJul 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahajanand Medical Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Ashok Seth, Principal investigator, Escorts Heart Institute & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811616
- Sponsor's protocol ID
- The MAXIMUS study
- Acronym
- Maximus
- Status last verified
- May 2025
- First submitted
- 18 Dec 2008
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seth A, Chandra P, Chouhan NS, Thakkar AS. A first-in-man study of sirolimus-eluting, biodegradable polymer coated cobalt chromium stent in real life patients. Indian Heart J. 2012 Nov-Dec;64(6):547-52. doi: 10.1016/j.ihj.2012.07.011. Epub 2012 Jul 27.
PubMed 23253405
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Efficacy Evaluation of Sirolimus Eluting Supralimus-Core™ Stent at MAX DDHV Institute in the Treatment of de Novo Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT00811616
- Acronym / sponsor ID
- Maximus / The MAXIMUS study
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Supralimus-Core™, de novo native coronary artery lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sahajanand Medical Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
The primary objective of this study is to assess the safety and efficacy of the Supralimus - Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease.
STUDY DESIGN:
This is a single centre, prospective study. Approximately 105 patients were enrolled in the study. Patients were followed for twelve months post-procedure. All patients were to have a repeat angiography at 8 months.
STUDY POPULATION:
The study population consisted of approximately 105 patients with de novo native vessel obstructive coronary artery disease with no specific criteria. Patients from the daily practice were included. Patients had to meet all eligibility criteria for inclusion into the study.
ENDPOINTS:
The primary safety endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at 30 days.
The primary efficacy endpoint is the in-stent binary restenosis rate at 8-month follow-up determined by off-line Quantitative Coronary Angiography.
The following secondary efficacy endpoints were assessed
- Angiographic success
- Procedure success
- Quantitative Coronary Angiography derived vessel parameters in-stent and 5 mm proximal and 5 mm distal from the edge of the stent: acute gain, MLD, % DS, late loss, mean diameter. In-stent pre-, post and at 8-month follow-up.
- Clinically justified Target Lesion Revascularization (TLR) at 12 months
The following secondary safety endpoints were assessed:
- MACE until 12 months
- Device related SAEs until 12 months
- Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after 30 days until 12 months)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supralimus™ Core™ Sirolimus eluting stent | Experimental | Device: Supralimus-Core™, Device: Supralimus™ Core™ Sirolimus eluting stentSupralimus™ Core™ Sirolimus eluting stent manufactured by Sahajanand Medical Technologies Limited intended to treat coronary artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient must be >= 18 years of age;
- Symptomatic ischemic heart disease (CCS class 1 -4 , Braunwald class IB, IC, IIB, IIC, IIIB,IIIC) and/or objective evidence of myocardial ischemia;
- Vessel size of >= 2.5 and <= 3.5mm.
- Target lesions which can be covered by stent in a manner lesion stent ratio of at least 1.5.
- Acceptable candidate for coronary artery bypass surgery (CABG);
Key exclusion criteria (13 listed)
- Women of childbearing potential;
- Impaired renal function (creatinine > 2.0 mg/dl or 177 µmol/l);
- Any patient who has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis);
- Recipient of heart transplant;
- Restenotic or lesion in graft.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supralimus-Core™Sirolimus Eluting Cobalt Chromium based coronary stent system | Device | Supralimus™ Core™ Sirolimus eluting stent |
| Supralimus™ Core™ Sirolimus eluting stentSupralimus™ Core™ Sirolimus eluting stent intended to treat coronary artery disease. | Device | Supralimus™ Core™ Sirolimus eluting stent |
Primary outcome
Primary safety endpoint: Major Adverse Cardiac Events (MACE)
Time frame: 30 days
Primary efficacy endpoint: In-stent binary restenosis rate determined by off-line Quantitative Coronary Angiography.
Time frame: 8 Month
2 secondary outcomes
Secondary safety endpoints: - MACE until 12 months, Device related SAEs until 12 months, Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after 30 days until 12 months)
Time frame: 12 months
Secondary efficacy endpoints: Angiographic, Procedure success; acute gain, MLD, % DS, LL, mean diameter; In-stent pre-,post,8-month follow-up; Clinically justified TLR at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 23253405Seth A, Chandra P, Chouhan NS, Thakkar AS. A first-in-man study of sirolimus-eluting, biodegradable polymer coated cobalt chromium stent in real life patients. Indian Heart J. 2012 Nov-Dec;64(6):547-52. doi: 10.1016/j.ihj.2012.07.011. Epub 2012 Jul 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Ashok Seth principal investigator
Escorts Heart Institute & Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supralimus-Core™ and Supralimus™ Core™ Sirolimus eluting stent in people with Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 1 site 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 7 inclusion and 13 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Primary safety endpoint: Major Adverse Cardiac Events (MACE) (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT00811616, 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 16 May 2025.