Coronary StenosisNCT00428662
Evaluation of a New Nanotechnology Based Drug-Eluting Stent for Opening of Narrowed Arteries of the Heart
A study testing drug eluting nonpolymeric nanoporous stent in people with Coronary Stenosis, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Coronary artery disease (CAD) is the largest cause of death and disability in the world. Besides medicines, the principle treatment of this condition requires opening of the narrowed arteries, responsible for angina and other symptoms of the disease, by angioplasty or surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- drug eluting nonpolymeric nanoporous stent
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2007to Oct 2007
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female 2: 18 years of age (note: females of child bearing potential must have a negative pregnancy test within 7 days of treatment and must use effective pregnancy avoidance until the 6 month angiogram is completed)
- Have chest pain consistent with angina pectoris or a history of documented myocardial infarction or documented silent ischemia
- Treatment of a native vessel de novo coronary lesion (only 1 single study lesion/patient)
- Target vesseI2.5mm-4.0mm in diameter (visual estimate)
- Target lesion length::: 12mm (visual estimate)
- Target lesion stenosis> 50% and < 100% (visual estimate)
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- At least TIMI grade II coronary flow
- Acceptable candidate for CABG surgery
- Patient is willing to come back for a follow-up evaluations including repeat cardiac catheterization 5-7 months after treatment
- Patient must provide written informed consent prior to the index procedure using a form that is approved by the local Ethics Committee
Who cannot join
- Patient has experienced an acute myocardial infarction (Q wave or non-Q wave) within 72 hours prior to the index procedure with CK enzymes 2: 2x the local laboratory upper limit of normal, with the presence of CK- MB levels elevated above the local laboratory upper limit of normal;
- Unprotected left main coronary disease with> 50% stenosis;
- Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede runoff;
- Ostial location of the target lesion;
- Angiographic evidence of thrombus within the target lesion;
- Severely calcified'lesion which cannot be successfully predilated;
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- Documented L VEF < 25%, or clinically significant congestive cardiac failure;
- Totally occluded vessel;
- Impaired renal function (creatinine> 0.27mmol/L) at the time of treatment;
- Pretreatment with devices other than balloon angioplasty;
- Excessive tortuosity proximal to the lesion which makes stent delivery and deployment uncertain;
- Target lesion involves a bifurcation including a diseased side branch> 2.5mm in diameter that would require treatment;
- Prior stenting within 5mm of the target lesion;
- Patient is a recipient of a heart transplant;
- Patient has a life expectancy < 12 months;
- Known allergies to clopidogrel bisulfate (Plavix@), ticlopidine (Ticlid@), Cobalt Chromium alloy and Paclitaxol that cannot be medically managed;
- In the investigator's opinion, any significant medical condition which may interfere with the patient's optimal participation in this study;
- Currently participating in an investigational drug or device study that has not completed the primary endpoint;
- Intervention of another coronary lesion has occurred within 30 days before or is planned within 30 days after the index procedure.
- In the investigator's opinion, the lesion is not suitable for stenting
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Balram Bhargava, MD, DM
About this study
Official title: Clinical and Angiographic Evaluation of Paclitaxel Eluting, Non-Polymeric, Nanoporous Carbon-Carbon Coated, Cobalt-Chromium Stent
Coronary artery disease (CAD) is the largest cause of death and disability in the world. Besides medicines, the principle treatment of this condition requires opening of the narrowed arteries, responsible for angina and other symptoms of the disease, by angioplasty or surgery. Introduction of metal scaffolds called 'stents' in the past few decades revolutionised the angioplasty technique, and has made it the most popular treatment today for CAD. However these stents are prone to becomin narrow and obstructed after implanataion, causing symptoms and non-fatal heart attacks in some patients. Introduction of stents that slowly release drugs locally to minimize this process, called 'drug-eluting stents'(DES)he past few years has been one of the biggest breakthroughs in the field of cardiology. However ven the current available DES are still prone to narrowing in high-risk patients, like those with diabetes, and also have a higher chance for sudden blockage by a blood clot even many years later after insertion. Thus it is important to develop technology for more efficacious and safer DES.This includes safer drugs, better stent design and delivery, and more inert platforms for drug release We hypothesise that a new stent made with nanoporous particle with better polymer for drug release will prove to be safer and more efficacious alternative to currently available DES.
- Conditions
- Coronary Stenosis
- Being tested
- drug eluting nonpolymeric nanoporous stent
- Keywords
- coronary stenting, drug eluting stents, paclitaxel, nanoporous
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug eluting nonpolymeric nanoporous stentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late loss as compared historically to other DES, within the stented segment post-procedure and at 6-9-month follow-up
Secondary outcomes (2)
Major adverse cardiac events
Stent thrombosis rate (acute, subacute, or chornic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startJan 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Balram Bhargava, MD, DM, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428662
- Sponsor's protocol ID
- 0101
- Status last verified
- Jan 2007
- First submitted
- 29 Jan 2007
- Last updated
- 30 Jan 2007
- Results posted
- No
Publications
Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
PubMed 12050336Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. doi: 10.1056/NEJMoa032441.
PubMed 14724301Bhargava B, Reddy NK, Karthikeyan G, Raju R, Mishra S, Singh S, Waksman R, Virmani R, Somaraju B. A novel paclitaxel-eluting porous carbon-carbon nanoparticle coated, nonpolymeric cobalt-chromium stent: evaluation in a porcine model. Catheter Cardiovasc Interv. 2006 May;67(5):698-702. doi: 10.1002/ccd.20698.
PubMed 16575925van der Giessen WJ, Lincoff AM, Schwartz RS, van Beusekom HM, Serruys PW, Holmes DR Jr, Ellis SG, Topol EJ. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation. 1996 Oct 1;94(7):1690-7. doi: 10.1161/01.cir.94.7.1690.
PubMed 8840862
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Angiographic Evaluation of Paclitaxel Eluting, Non-Polymeric, Nanoporous Carbon-Carbon Coated, Cobalt-Chromium Stent
- ClinicalTrials.gov ID
- NCT00428662
- Acronym / sponsor ID
- 0101
- Conditions
- Coronary Stenosis
- Keywords
- coronary stenting, drug eluting stents, paclitaxel, nanoporous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Oct 2007
- First posted
- 30 Jan 2007 (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.
Coronary artery disease (CAD) is the largest cause of death and disability in the world. Besides medicines, the principle treatment of this condition requires opening of the narrowed arteries, responsible for angina and other symptoms of the disease, by angioplasty or surgery. Introduction of metal scaffolds called 'stents' in the past few decades revolutionised the angioplasty technique, and has made it the most popular treatment today for CAD. However these stents are prone to becomin narrow and obstructed after implanataion, causing symptoms and non-fatal heart attacks in some patients. Introduction of stents that slowly release drugs locally to minimize this process, called 'drug-eluting stents'(DES)he past few years has been one of the biggest breakthroughs in the field of cardiology. However ven the current available DES are still prone to narrowing in high-risk patients, like those with diabetes, and also have a higher chance for sudden blockage by a blood clot even many years later after insertion. Thus it is important to develop technology for more efficacious and safer DES.This includes safer drugs, better stent design and delivery, and more inert platforms for drug release We hypothesise that a new stent made with nanoporous particle with better polymer for drug release will prove to be safer and more efficacious alternative to currently available DES.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or non-pregnant female 2: 18 years of age (note: females of child bearing potential must have a negative pregnancy test within 7 days of treatment and must use effective pregnancy avoidance until the 6 month angiogram is completed)
- Have chest pain consistent with angina pectoris or a history of documented myocardial infarction or documented silent ischemia
- Treatment of a native vessel de novo coronary lesion (only 1 single study lesion/patient)
- Target vesseI2.5mm-4.0mm in diameter (visual estimate)
- Target lesion length::: 12mm (visual estimate)
Key exclusion criteria (20 listed)
- Patient has experienced an acute myocardial infarction (Q wave or non-Q wave) within 72 hours prior to the index procedure with CK enzymes 2: 2x the local laboratory upper limit of normal, with the presence of CK- MB levels elevated above the local laboratory upper limit of normal;
- Unprotected left main coronary disease with> 50% stenosis;
- Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede runoff;
- Ostial location of the target lesion;
- Angiographic evidence of thrombus within the target lesion;
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 |
|---|---|---|
| drug eluting nonpolymeric nanoporous stent | Device | – |
Primary outcome
In-stent late loss as compared historically to other DES, within the stented segment post-procedure and at 6-9-month follow-up
2 secondary outcomes
Major adverse cardiac events
Stent thrombosis rate (acute, subacute, or chornic)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2007.
- Background: PubMed 12050336Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
- Background: PubMed 14724301Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. doi: 10.1056/NEJMoa032441.
- Background: PubMed 16575925Bhargava B, Reddy NK, Karthikeyan G, Raju R, Mishra S, Singh S, Waksman R, Virmani R, Somaraju B. A novel paclitaxel-eluting porous carbon-carbon nanoparticle coated, nonpolymeric cobalt-chromium stent: evaluation in a porcine model. Catheter Cardiovasc Interv. 2006 May;67(5):698-702. doi: 10.1002/ccd.20698.
- Background: PubMed 8840862van der Giessen WJ, Lincoff AM, Schwartz RS, van Beusekom HM, Serruys PW, Holmes DR Jr, Ellis SG, Topol EJ. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation. 1996 Oct 1;94(7):1690-7. doi: 10.1161/01.cir.94.7.1690.
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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.
Balram Bhargava, MD, DM principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug eluting nonpolymeric nanoporous stent in people with Coronary Stenosis, run by All India Institute of Medical Sciences 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 10 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 30 Jan 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Balram Bhargava, MD, DM (91-11-26588663, balrambhargava@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent late loss as compared historically to other DES, within the stented segment post-procedure and at 6-9-month follow-up. 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 NCT00428662, which also lists 4 linked publications.
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 30 Jan 2007.