Coronary Artery DiseasePhase 4NCT00936780
Infinnium-Core™ Registry for the Treatment of Patients With De Novo Coronary Lesions
A Phase 4 study testing Infinnium-Core™ Paclitaxel eluting Coronary Stent in people with Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 7 sites in India.
Trial 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. 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?
- Infinnium-Core™ Paclitaxel eluting Coronary Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 7 sitesIndia
- Study dates
- Jul 2008to Mar 2011
- Phase
- Phase 4
- 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 ≤ 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.
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, 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).
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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 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.
- 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 6 months after the index procedure.
- Life expectancy less than 1 year.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Sri Ramakrishna Heart Foundation & Research Centre
Coimbatore, Tamil Nadu, 641 044
CHL Apollo Hospitals,
Indore, Madhya Pradesh, 452008
CHL Apollo Hospitals
Indore, Madhya Pradesh, 452008
Government Medical College & Super Speciality Hospital
Nagpur, Maharashtra, 440003
Arneja Heart Institute
Nagpur, Maharashtra, 440010
Bankers Heart Institute
Vadodara, Gujarat, 390 015
Baroda Heart Institute & Research Center
Vadodara, Gujarat, 390007
About this study
Official title: Safety and Efficacy of the Infinnium-Core™ Paclitaxel-Eluting Coronary Stent System for the Treatment of Patients With De Novo Coronary Lesions
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Infinnium-Core™ Paclitaxel eluting Coronary Stent
- Keywords
- Coronary Artery Disease, Restenosis, Stent thrombosis, Coronary stents, Angioplasty, Drug Eluting Stents (DES)
- 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.
Infinnium-Core™ Paclitaxel eluting Coronary StentDevice
Also called Drug Eluting Stent (DES)
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.
| Study group | Role | What they receive |
|---|---|---|
| Infinnium-Core™ Paclitaxel eluting Coronary Stent | Experimental | Not described Receives: Device: Infinnium-Core™ Paclitaxel eluting Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE)
Measured: 30 days and 9 month
Secondary outcomes (1)
ANGIOGRAPHIC
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
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 posted10 Jul 2009 (estimated)
- Study startJul 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: market demand from paclitaxel to sirolimus drug-eluting stent
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahajanand Medical Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936780
- Sponsor's protocol ID
- IC001: V1.1
- Status last verified
- Aug 2012
- First submitted
- 8 Jul 2009
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Infinnium-Core™ Paclitaxel-Eluting Coronary Stent System for the Treatment of Patients With De Novo Coronary Lesions
- ClinicalTrials.gov ID
- NCT00936780
- Acronym / sponsor ID
- IC001: V1.1
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Restenosis, Stent thrombosis, Coronary stents, Angioplasty, Drug Eluting Stents (DES)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: market demand from paclitaxel to sirolimus drug-eluting stent
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Sahajanand Medical Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jul 2009 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infinnium-Core™ Paclitaxel eluting Coronary Stent | Experimental | Device: Infinnium-Core™ Paclitaxel eluting Coronary Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
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 |
|---|---|---|
| Infinnium-Core™ Paclitaxel eluting Coronary StentAlso: Drug Eluting Stent (DES)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. | Device | Infinnium-Core™ Paclitaxel eluting Coronary Stent |
Primary outcome
Major Adverse Cardiac Events (MACE)
Time frame: 30 days and 9 month
1 secondary outcome
ANGIOGRAPHIC
Time frame: 12 months
Results and safety
The study was stopped early (reason given: market demand from paclitaxel to sirolimus drug-eluting stent). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infinnium-Core™ Paclitaxel eluting Coronary Stent in people with Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 7 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 23 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: stopped early, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: market demand from paclitaxel to sirolimus drug-eluting stent). Results are not available in the source record.
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?
Major Adverse Cardiac Events (MACE) (time frame: 30 days and 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2012.