Coronary Artery DiseaseCONFIRM 1NCT00689767
COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms (CONFIRM 1)
A study testing CINATRA™ Coronary Stent System and CINATRA™ ISA 247 Coated Coronary Stent System in people with Coronary Artery Disease, run by Atrium Medical Corporation at 7 sites in Belgium.
Trial summary
This First In Man study is a prospective, multicentre, single blind, randomized, controlled clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7 sites. 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?
- CINATRA™ Coronary Stent System and CINATRA™ ISA 247 Coated Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 7 sitesBelgium
- Study dates
- Jun 2008to Jul 2012
- 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
- Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2, 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia.
- Patients who are eligible for coronary revascularization (percutanous angioplasty).
- Acceptable candidates for coronary artery bypass grafting (CABG).
- Patients with de novo lesion in a native coronary artery >50% and <100% stenosis.
- NOTE: Treatment of lesions in a non-target vessel is up to the investigator's discretion (max. two-vessel-disease).
- ONLY a bare metal stent (no drug eluting stent) can be used for this treatment. Treatment of any non-target vessel lesions must be successfully completed before enrolling patient and placing study stent.
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- The target lesion must be a maximum length of 13 mm (visual estimate) and able to be covered by one stent.
- The reference diameter of the target lesion must be 3.0 mm by visual estimate.
- Left ventricular ejection fraction of >30%.
- Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.
Who cannot join
- Patients under the age of 18 or unable to give informed consent.
- Women who are pregnant. Women of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable contraception at a minimum until after the angiographic follow up.
- Patients who previously participated in this study.
- Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- NOTE: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.).
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- Patients who intend to have a major surgical intervention within 6 months of enrollment in the study.
- Patients with new ST elevation within 48 hours prior to stenting.
- Braunwald Class IA, IIA and IIIA angina pectoris.
- Patients with a contraindication to an emergency coronary bypass surgery.
- Patients who had previous Coronary Artery Bypass Surgery (CABG).
- Any individual who may refuse a blood transfusion.
- Serum creatinine >3.0 mg/dL.
- Platelet count <100,000 cells/mm³.
- Patients with intolerance or contraindication to acetylsalicylic acid (aspirin), heparin, cyclosporin or cyclosporine derivative, clopidogrel or ticlopidine drug therapy.
- Patients with contrast agent hypersensitivity that cannot be adequately pre-medicated.
- Patients who have a stent anywhere within the target vessel.
- Any planned interventional treatment of any vessel post study procedure.
- Patients with previous PCI of the same segment (i.e. no restenotic lesions).
- Previous interventional procedure (less than 6 months) anywhere within the target vessel;
- Target lesion is located in or supplied by an arterial or venous bypass graft.
- Target lesion involves a side branch >2.0mm in diameter.
- Ostial target lesion (within 3.0mm of vessel origin).
- Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment .
- Patients with total occlusions (TIMI 0).
- Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off.
- Target lesion requires treatment with a device other than the predilatation balloon prior to stent placement (including but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, cutting balloon etc.).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
Middelheim Hospital
Antwerp
Imelda ziekenhuis
Bonheiden, 2820
Cliniques universitaires Saint-Luc
Brussels, 1200
Ziekenhuis Oost Limburg, Campus Sint Jan
Genk, 3600
Algemeen Ziekenhuis Maria Middelares
Ghent, 9000
Virga Jesse Ziekenhuis
Hasselt, 3500
UZ Leuven Cardiovascular Institute
Leuven, 3000
About this study
Official title: COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms
This First In Man study is a prospective, multicentre, single blind, randomized, controlled clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7 sites. Clinical follow up will occur at 1 month, 6 months, and 1, 2, 3, 4 and 5 years post procedure. Repeat angiography and IVUS will be performed at the 6 month follow up time point for all subjects.
- Conditions
- Coronary Artery Disease
- Being tested
- CINATRA™ Coronary Stent System, CINATRA™ ISA 247 Coated Coronary Stent System
- Keywords
- drug eluting stent
- 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.
CINATRA™ Coronary Stent SystemDevice
Bare metal cobalt chromium stent implantation
CINATRA™ ISA 247 Coated Coronary Stent SystemDevice
Drug coated cobalt chromium stent implantation
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | This arm will receive the coated stent Receives: Device: CINATRA™ ISA 247 Coated Coronary Stent System |
| B | Active comparator | This arm will receive a bare metal stent Receives: Device: CINATRA™ Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Lumen Loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJul 2012
Why it stopped: Terminated ahead of schedule after completion of the 3-year follow-up time point due to Sponsor decision.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrium Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Van Langenhove, MD, Principal investigator, Middelheim Hospital, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689767
- Sponsor's protocol ID
- 801
- Other IDs
- Application #: 2008-001347-20
- Acronym
- CONFIRM 1
- Status last verified
- Apr 2013
- First submitted
- 2 Jun 2008
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms
- ClinicalTrials.gov ID
- NCT00689767
- Acronym / sponsor ID
- CONFIRM 1 / 801
- Conditions
- Coronary Artery Disease
- Keywords
- drug eluting stent
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated ahead of schedule after completion of the 3-year follow-up time point due to Sponsor decision.
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Atrium Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 Jun 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.
This First In Man study is a prospective, multicentre, single blind, randomized, controlled clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7 sites. Clinical follow up will occur at 1 month, 6 months, and 1, 2, 3, 4 and 5 years post procedure. Repeat angiography and IVUS will be performed at the 6 month follow up time point for all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: CINATRA™ ISA 247 Coated Coronary Stent SystemThis arm will receive the coated stent |
| B | Active comparator | Device: CINATRA™ Coronary Stent SystemThis arm will receive a bare metal stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2, 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia.
- Patients who are eligible for coronary revascularization (percutanous angioplasty).
- Acceptable candidates for coronary artery bypass grafting (CABG).
- Patients with de novo lesion in a native coronary artery >50% and <100% stenosis.
- NOTE: Treatment of lesions in a non-target vessel is up to the investigator's discretion (max. two-vessel-disease).
Key exclusion criteria (27 listed)
- Patients under the age of 18 or unable to give informed consent.
- Women who are pregnant. Women of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable contraception at a minimum until after the angiographic follow up.
- Patients who previously participated in this study.
- Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- NOTE: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
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 |
|---|---|---|
| CINATRA™ Coronary Stent SystemBare metal cobalt chromium stent implantation | Device | B |
| CINATRA™ ISA 247 Coated Coronary Stent SystemDrug coated cobalt chromium stent implantation | Device | A |
Primary outcome
Late Lumen Loss
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Terminated ahead of schedule after completion of the 3-year follow-up time point due to Sponsor decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
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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.
Glenn Van Langenhove, MD principal investigator
Middelheim Hospital, Antwerp, Belgium
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CINATRA™ Coronary Stent System and CINATRA™ ISA 247 Coated Coronary Stent System in people with Coronary Artery Disease, run by Atrium Medical Corporation at 7 sites in Belgium.
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 27 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 17 Apr 2013. 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 Belgium. 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 was stopped early (reason given: Terminated ahead of schedule after completion of the 3-year follow-up time point due to Sponsor decision.). 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?
Late Lumen Loss (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 Apr 2013.