STEMIPhase 3APPOSITION llNCT01008085
STENTYS Self-expanding Versus Balloon-expandable Stent in Acute Myocardial Infarction (AMI)
A Phase 3 study testing Stentys coronary stent and Balloon-expandable stent in people with STEMI, run by Stentys at 1 site in France.
Trial summary
Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the struts to the vessel wall than a balloon-expandable stent within a few days after the procedure in acute myocardial infarction patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI
- What is being tested?
- Stentys coronary stent and Balloon-expandable stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Dec 2010
- Phase
- Phase 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
- Subject 18 years old.
- Acute Myocardial Infarction defined as presence of at least two of the three items below:
- Detection of rise of cardiac biomarkers with a least one value above the 99th percentile of the upper reference limit (URL)
- Symptoms of ischaemia (chest pain) >20 minutes
- ECG changes indicative of new ischaemia: new ST-T changes (ST deviation ≥0.2mV precordial leads and/or ≥0.1mV limb leads) or new LBBB)
- Reperfusion expected to be achieved within 12 hours from the onset of symptoms
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- Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
- Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.
- Acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Male or non-pregnant female subject.
- Angiographic Inclusion Criteria:
- Reference vessel diameter >2.5mm and <4.0mm by visual estimate.
- Target lesion <30mm in length by visual estimate
Who cannot join
- Currently enrolled in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- Coronary or cardiac intervention or major surgery of any kind within 30 days prior to the procedure.
- Target vessel supplied by by-pass vessel
- Patients on anticoagulation therapy (Coumadin)
- Patient received thrombolytic therapy.
- Myocardial infarction due to stent thrombosis, or infarct lesion at the side of a previously implanted stent
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- Cardiogenic shock
- Any previous stent placement within 10mm (proximal or distal) of the target lesion.
- Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.
- Concurrent medical condition with a life expectancy of less than 6 months.
- Left ventricular ejection fraction (LVEF) <30% at the most recent evaluation.
- Cerebrovascular accident or transient ischemic attack in the last 6 months.
- Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- Known serum creatinine level >2.5mg/dl or presence or history of renal failure
- Angiographic Exclusion Criteria:
- Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the left anterior descending (LAD) or left circumflex (LCX) artery or a branch thereof).
- Target vessel is excessively tortuous (two bends >90˚ to reach the target lesion).
- Lesion location that is aorto-ostial or within 5mm of the origin of the LAD or LCX.
- Target lesion is severely calcified.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction - APPOSITION II
Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the struts to the vessel wall than a balloon-expandable stent within a few days after the procedure in acute myocardial infarction patients.
Read the detailed description
Stent strut malapposition and stent underexpansion are a common phenomenon in AMI as a result of the changing anatomy after an AMI has occurred (thrombus dissolution, resolution of spasm) with the traditional balloon-expandable stent treatment. A self-expanding stent might lead to better stent strut apposition as it follows the contours of the vessel wall due to its self-expanding properties. This might result into better long term clinical outcomes like lower thrombosis rates.
- Conditions
- STEMI
- Being tested
- Stentys coronary stent, Balloon-expandable stent
- Keywords
- STEMI, self-expandable, balloon-expandable
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stentys coronary stentDevice
Also called Self-expanding stent
Self-expanding Nitinol stent
Balloon-expandable stentDevice
Also called VISION/Driver
VISION/Driver
| Study group | Role | What they receive |
|---|---|---|
| Self-expanding stent | Experimental | Stentys stent Receives: Device: Stentys coronary stent |
| Balloon-expandable stent | Active comparator | VISION/Driver Receives: Device: Balloon-expandable stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent strut apposition measured by optical coherence tomography (OCT)
Measured: 3 days after procedure
Secondary outcomes (1)
Stent thrombosis
Measured: 30 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stentys
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stefan Verheye, MD, Ph.D, Principal investigator, ZNA, Middelheim, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008085
- Sponsor's protocol ID
- ST2009-02
- Acronym
- APPOSITION ll
- Status last verified
- Jan 2011
- First submitted
- 4 Nov 2009
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nakatani S, Onuma Y, Ishibashi Y, Karanasos A, Regar E, Garcia-Garcia HM, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Capodanno D, Van Langenhove G, Verheye S, Serruys PW, van Geuns RJ. Incidence and potential mechanism of resolved, persistent and newly acquired malapposition three days after implantation of self-expanding or balloon-expandable stents in a STEMI population: insights from optical coherence tomography in the APPOSITION II study. EuroIntervention. 2015 Dec;11(8):885-94. doi: 10.4244/EIJY15M11_01.
PubMed 26549374van Geuns RJ, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Garcia-Garcia HM, Regar E, Capodanno D, Van Langenhove G, Verheye S. Self-expanding versus balloon-expandable stents in acute myocardial infarction: results from the APPOSITION II study: self-expanding stents in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Dec;5(12):1209-19. doi: 10.1016/j.jcin.2012.08.016.
PubMed 23257368
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction - APPOSITION II
- ClinicalTrials.gov ID
- NCT01008085
- Acronym / sponsor ID
- APPOSITION ll / ST2009-02
- Conditions
- STEMI
- Keywords
- STEMI, self-expandable, balloon-expandable
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- StentysIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Nov 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.
Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the struts to the vessel wall than a balloon-expandable stent within a few days after the procedure in acute myocardial infarction patients.
Detailed description
Stent strut malapposition and stent underexpansion are a common phenomenon in AMI as a result of the changing anatomy after an AMI has occurred (thrombus dissolution, resolution of spasm) with the traditional balloon-expandable stent treatment. A self-expanding stent might lead to better stent strut apposition as it follows the contours of the vessel wall due to its self-expanding properties. This might result into better long term clinical outcomes like lower thrombosis rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-expanding stent | Experimental | Device: Stentys coronary stentStentys stent |
| Balloon-expandable stent | Active comparator | Device: Balloon-expandable stentVISION/Driver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject 18 years old.
- Acute Myocardial Infarction defined as presence of at least two of the three items below:
- Reperfusion expected to be achieved within 12 hours from the onset of symptoms
- Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
- Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.
Key exclusion criteria (19 listed)
- Currently enrolled in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- Coronary or cardiac intervention or major surgery of any kind within 30 days prior to the procedure.
- Target vessel supplied by by-pass vessel
- Patients on anticoagulation therapy (Coumadin)
- Patient received thrombolytic therapy.
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 |
|---|---|---|
| Stentys coronary stentAlso: Self-expanding stentSelf-expanding Nitinol stent | Device | Self-expanding stent |
| Balloon-expandable stentAlso: VISION/DriverVISION/Driver | Device | Balloon-expandable stent |
Primary outcome
Stent strut apposition measured by optical coherence tomography (OCT)
Time frame: 3 days after procedure
1 secondary outcome
Stent thrombosis
Time frame: 30 days and 6 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 24 Jan 2011.
- Derived from this study: PubMed 26549374Nakatani S, Onuma Y, Ishibashi Y, Karanasos A, Regar E, Garcia-Garcia HM, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Capodanno D, Van Langenhove G, Verheye S, Serruys PW, van Geuns RJ. Incidence and potential mechanism of resolved, persistent and newly acquired malapposition three days after implantation of self-expanding or balloon-expandable stents in a STEMI population: insights from optical coherence tomography in the APPOSITION II study. EuroIntervention. 2015 Dec;11(8):885-94. doi: 10.4244/EIJY15M11_01.
- Derived from this study: PubMed 23257368van Geuns RJ, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Garcia-Garcia HM, Regar E, Capodanno D, Van Langenhove G, Verheye S. Self-expanding versus balloon-expandable stents in acute myocardial infarction: results from the APPOSITION II study: self-expanding stents in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Dec;5(12):1209-19. doi: 10.1016/j.jcin.2012.08.016.
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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.
Stefan Verheye, MD, Ph.D principal investigator
ZNA, Middelheim, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stentys coronary stent and Balloon-expandable stent in people with STEMI, run by Stentys at 1 site 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 13 inclusion and 19 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 24 Jan 2011. 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 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 phase mean?
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?
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?
Stent strut apposition measured by optical coherence tomography (OCT) (time frame: 3 days after procedure). 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 NCT01008085, which also lists 2 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 24 Jan 2011.