STENTYS Self-expanding Versus Balloon-expandable Stent in Acute Myocardial Infarction (AMI)

NCT01008085 | Completed Phase 3 DMC

• 1 other identifier: ST2009-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

STEMI

Keywords

STEMI; self-expandable; balloon-expandable

Outcome Measures

Primary Outcomes (1)

• Stent strut apposition measured by optical coherence tomography (OCT)

  3 days after procedure

Secondary Outcomes (1)

• Stent thrombosis

  30 days and 6 months

Study Arms (2)

Self-expanding stent

EXPERIMENTAL

Stentys stent

Device: Stentys coronary stent

Balloon-expandable stent

ACTIVE COMPARATOR

VISION/Driver

Device: Balloon-expandable stent

Interventions

Stentys coronary stent DEVICE

Self-expanding Nitinol stent

Also known as: Self-expanding stent

Self-expanding stent

Balloon-expandable stent DEVICE

VISION/Driver

Also known as: VISION/Driver

Balloon-expandable stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Reference vessel diameter \>2.5mm and \<4.0mm by visual estimate.
• Target lesion \<30mm in length by visual estimate

You may not qualify if:

• 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
• 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
• 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).

Sponsors & Collaborators

• Stentys: lead

Study Sites (1)

C. Spaulding

Paris, France

Location

Related Publications (2)

• 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.

  PMID: 26549374 DERIVED

• van 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.

  PMID: 23257368 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Stefan Verheye, MD, Ph.D

  ZNA, Middelheim, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: November 5, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 24, 2011

Record last verified: 2011-01

Locations

FR (1)