LesionPhase 2/3ANSWERSNCT00790283
Assessment of the Numen Stent With Evaluation in a Randomized Study
A Phase 2/3 study testing PTCA with stent implantation in people with Lesion, run by International Biomedical Systems S.p.A. at 8 sites in France.
Trial summary
The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native coronary arteries and compare it to the VISION/MINIVISION coronary stent Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lesion
- What is being tested?
- PTCA with stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 8 sitesFrance
- Study dates
- Sep 2008to Sep 2009
- Phase
- Phase 2/3
- 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
- Clinical or instrumental documentation of stable/unstable myocardial ischemia or angina with a >50% lesion on a major coronary vessel and/or side branch > 2.0 mm
- Lesion length ≤ 20 mm
- Vessel requiring stent size with diameter ≥ 2.5 mm
Who cannot join
- Age < 18 years
- Life expectancy < 6 months
- Chronic renal failure (serum creatinine > 2 mg %)
- Ongoing acute myocardial infarction
- Left ventricular ejection fraction (LVEF) <30%
- Cardiogenic shock
Show all 24Show fewer
- Documented or suspected systemic and/or infectious disease
- Hypersensitivity to cobalt chromium or contrast media
- Anti-thrombotic drug intolerance
- Cardiac and/or extracardiac documented disease requiring surgical repair
- Patient is not an acceptable candidate for emergent coronary artery bypass surgery
- Primary or secondary pulmonary hypertension (by echo-doppler)
- Planned > 2 stent implantation (except bail-out)
- Recent (< 6 months) PCI or CABG
- Other type of stent implantation (also in case of bail-out)
- Visible endocoronary thrombosis
- Diffuse, severe coronary calcifications
- Use of debulking devices
- Extreme vessel tortuosity
- Unprotected left main stenosis (ULM)
- Bifurcation lesion
- In stent restenosis (ISR)
- Saphenous vein graft (SVG) and arterial by pass (internal mammary artery,IMA)
- Chronic total occlusion (CTO)
Trial locations and contacts
8 sites in 1 country.
Thierry Corcos, MD, FACC contact
8 sites in 1 country
France8 sites, 2 recruiting
- Active, not recruiting
CHU Cote de Nacre
Caen, 14033
- Active, not recruiting
CMC De Parly II
Le Chesnay, 78150
- Active, not recruiting
Clinique Valmente
Marseille, 13009
- Recruiting
Centre Hospitalier Privé Beauregard
Marseille, 13012
Olivier Wittemberg, 0033491121090, olwitt@aol.com
Olivier Wittemberg
- Active, not recruiting
Clinique Vert Coteau
Marseille, 13375
- Not yet recruiting
Clinique Turin
Paris, 75006
Thierry Corcos, MD, FACC
- Active, not recruiting
Clinique Alleray-Labrouste
Paris, 75018
- Active, not recruiting
Clinique Saint Gatien
Tours, 37042
About this study
The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native coronary arteries and compare it to the VISION/MINIVISION coronary stent
Read the detailed description
The success of bare metal coronary stenting is limited by the restenosis phenomenon, with rates depending on patient vascular morphology and lesion-related factors, the indication for and technique of stent deployment, and others. Drug-eluting stents (DES) improve the treatment of many coronary artery lesions by significantly reducing in-stent restenosis. However, there have numerous limitations resulting from the need for long-term dual antiplatelet therapy, the consequent bleeding risk (old patients, surgery, colon or gastric cancer, trauma), the unknown side-effects of long-term antiplatelet therapy, the cost associated with a long-term thienopyridine regimen, the body's reaction to the stent polymer, and the 0.2% per year increase in late stent thrombosis in comparison with bare metal stents (BMS).
For these reasons, continuous research is devoted to improve the effectiveness of bare metal stents. The ideal stent should be non-thrombogenic, with a low rate of restenosis and late thrombotic events. The NUMEN stent has been designed to meet these criteria, using an extremely low stent strut thickness.
- Conditions
- Lesion
- Being tested
- PTCA with stent implantation
- Keywords
- Treatment of de novo lesions in native coronary arteries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTCA with stent implantationDevice
Eligible patients will be randomly assigned to the implantation of one (or more) Numen or Vision/Mini Vision stent.
Each patient will undergo a 1-month follow-up and a clinical visit at 6 months from the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Numen | Experimental | Not described Receives: Device: PTCA with stent implantation |
| Vision/MiniVision | Active comparator | Not described Receives: Device: PTCA with stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification)
Measured: 6 months
Secondary outcomes (4)
Any death, cardiac death, stent related fatal / non fatal MI, TVR
Measured: 1 month
Any death, cardiac death, stent related fatal / non fatal MI, TVR
Measured: 6 months
Cardiac death, fatal/non fatal MI
Measured: In hospital
Procedural success, TLR, TVR, ST
Measured: In hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LesionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Biomedical Systems S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thierry Corcos, MD, FACC, Principal investigator, Clinique Turin, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790283
- Sponsor's protocol ID
- IBS/04-2007
- Other IDs
- 2008-A00111-54
- Acronym
- ANSWERS
- Status last verified
- Feb 2009
- First submitted
- 12 Nov 2008
- Last updated
- 17 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Numen Stent With Evaluation in a Randomized Study
- ClinicalTrials.gov ID
- NCT00790283
- Acronym / sponsor ID
- ANSWERS / IBS/04-2007
- Conditions
- Lesion
- Keywords
- Treatment of de novo lesions in native coronary arteries
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- International Biomedical Systems S.p.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 13 Nov 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.
The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native coronary arteries and compare it to the VISION/MINIVISION coronary stent
Detailed description
The success of bare metal coronary stenting is limited by the restenosis phenomenon, with rates depending on patient vascular morphology and lesion-related factors, the indication for and technique of stent deployment, and others. Drug-eluting stents (DES) improve the treatment of many coronary artery lesions by significantly reducing in-stent restenosis. However, there have numerous limitations resulting from the need for long-term dual antiplatelet therapy, the consequent bleeding risk (old patients, surgery, colon or gastric cancer, trauma), the unknown side-effects of long-term antiplatelet therapy, the cost associated with a long-term thienopyridine regimen, the body's reaction to the stent polymer, and the 0.2% per year increase in late stent thrombosis in comparison with bare metal stents (BMS).
For these reasons, continuous research is devoted to improve the effectiveness of bare metal stents. The ideal stent should be non-thrombogenic, with a low rate of restenosis and late thrombotic events. The NUMEN stent has been designed to meet these criteria, using an extremely low stent strut thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Numen | Experimental | Device: PTCA with stent implantation |
| Vision/MiniVision | Active comparator | Device: PTCA with stent implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Clinical or instrumental documentation of stable/unstable myocardial ischemia or angina with a >50% lesion on a major coronary vessel and/or side branch > 2.0 mm
- Lesion length ≤ 20 mm
- Vessel requiring stent size with diameter ≥ 2.5 mm
Key exclusion criteria (24 listed)
- Age < 18 years
- Life expectancy < 6 months
- Chronic renal failure (serum creatinine > 2 mg %)
- Ongoing acute myocardial infarction
- Left ventricular ejection fraction (LVEF) <30%
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 |
|---|---|---|
| PTCA with stent implantationEligible patients will be randomly assigned to the implantation of one (or more) Numen or Vision/Mini Vision stent. Each patient will undergo a 1-month follow-up and a clinical visit at 6 months from the procedure. | Device | Numen, Vision/MiniVision |
Primary outcome
Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification)
Time frame: 6 months
4 secondary outcomes
Any death, cardiac death, stent related fatal / non fatal MI, TVR
Time frame: 1 month
Any death, cardiac death, stent related fatal / non fatal MI, TVR
Time frame: 6 months
Cardiac death, fatal/non fatal MI
Time frame: In hospital
Procedural success, TLR, TVR, ST
Time frame: In hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2009.
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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.
Thierry Corcos, MD, FACC contact
Thierry Corcos, MD, FACC principal investigator
Clinique Turin, Paris, France
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PTCA with stent implantation in people with Lesion, run by International Biomedical Systems S.p.A. at 8 sites in France.
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 4 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: status not confirmed, as of the sponsor's last update on 17 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Thierry Corcos, MD, FACC (+33-(0)1-40-088806), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification) (time frame: 6 months). 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 17 Feb 2009.