ST-elevation Myocardial Infarction (STEMI) Clinical Trial
— STRATEGY-ITOfficial title:
A Prospective Evaluation of a Standardized Strategy for the Use of Bioresorbable Vascular Scaffold in ST-segment Elevation Myocardial Infarction: the BVS STEMI STRATEGY-IT Registry
BVS STEMI STRATEGY-IT is a spontaneous, prospective, non-randomized, single-arm multicenter
registry on consecutive STEMI patients eligible to undergo primary percutaneous coronary
intervention (PPCI) with BVS implantation on the basis of the pre-specified inclusion and
exclusion criteria.
This registry has the objective to assess the immediate (peri-procedural and 30 days), mid
(6 months and 1 year) and long-term (3 and 5 years) results following BVS implantation using
a pre-specified implantation strategy during PPCI in STEMI subjects.
Status | Active, not recruiting |
Enrollment | 500 |
Est. completion date | December 2021 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset <12 hours from hospital admission eligible for PPCI and BVS implantation; 2. Signed Patient Informed Consent/Data Release Form. Exclusion Criteria: 1. Age >75 years or <18 years; 2. Cardiogenic shock; 3. Pregnancy or breastfeeding; 4. Infarct-artery max diameter (within planned device deployment segment) <2.5 or >3.7 mm; 5. Stent thrombosis/restenosis as a culprit lesion; 6. Acute occlusion of a saphenous vein graft as a culprit lesion; 7. Culprit lesion involving a bifurcation which requires a 2-stent strategy as intention-to-treat; 8. Culprit lesion involving a long diseased segment requiring hybrid (overlap BVS-DES) treatment; 9. Dialysis; 10. Comorbidities with life expectancy <3 years; 11. Contraindication to 12 months dual anti-platelet therapy; 12. Severe calcification or/tortuosity in the segments proximal to the culprit lesion; 13. Absolute indication to chronic anticoagulation therapy; 14. Elective or emergent cardiac surgery intervention within 1 year after PPCI (i.e. inferior STEMI with critical unprotected left main disease or mechanical complications of STEMI). |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Cardiology Division, Azienda Ospedaliera Bolognini Seriate | Seriate (BG) |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Bolognini di Seriate Bergamo |
Italy,
Brugaletta S, Gori T, Low AF, Tousek P, Pinar E, Gomez-Lara J, Scalone G, Schulz E, Chan MY, Kocka V, Hurtado J, Gomez-Hospital JA, Münzel T, Lee CH, Cequier A, Valdés M, Widimsky P, Serruys PW, Sabaté M. Absorb bioresorbable vascular scaffold versus ever — View Citation
Cortese B, Ielasi A, Romagnoli E, Varricchio A, Cuculo A, Loi B, Pisano F, Corrado D, Sesana M, La Vecchia L, Summaria F, Tespili M, Silva Orrego P, Tognoni G, Steffenino G. Clinical Comparison With Short-Term Follow-Up of Bioresorbable Vascular Scaffold — View Citation
Ielasi A, Cortese B, Varricchio A, Tespili M, Sesana M, Pisano F, Loi B, Granata F, Moscarella E, Silva Orrego P, La Vecchia L, Steffenino G; RAI registry investigators.. Immediate and midterm outcomes following primary PCI with bioresorbable vascular sca — View Citation
Ielasi A, Varricchio A, Campo G, Leoncini M, Cortese B, Vicinelli P, Brugaletta S, di Uccio FS, Latib A, Tespili M. A prospective evaluation of a standardized strategy for the use of a polymeric everolimus-eluting bioresorbable scaffold in ST-segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY-IT study. Catheter Cardiovasc Interv. 2016 Oct 24. doi: 10.1002/ccd.26801. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device oriented composite end-point (DOCE) | A device oriented composite end-point of cardiac death, any myocardial infarction (STEMI or NSTEMI) clearly attributable to the-intervention culprit vessel (TV-MI) and ischemic driven TLR within 30 days after the index procedure. | 30 days | Yes |
Secondary | Procedural Success | Procedural success defined as BVS implantation at the "culprit" lesion site with less than 20% final stenosis and distal TIMI 3 flow. | 0-7 days | No |
Secondary | Device oriented composite end-point (DOCE) | A device oriented composite end-point (cardiac death, any myocardial infarction [STEMI or NSTEMI] clearly attributable to the-intervention culprit vessel [TV-MI] and ischemic driven TLR) at 6 months, 1-, 3-, and 5-years follow-up. | 6 months; 1, 3, 5 years | Yes |
Secondary | BVS Thrombosis | Any Definite/Probable BVS thrombosis (in-hospital and at follow-up). | In Hospital and at follow-up (up to 5 years) | Yes |
Secondary | Any Bleeding | Bleedings defined according to the Bleeding Academic Research Consortium (BARC) | In Hospital and at follow-up (up to 5 years) | Yes |
Secondary | Major adverse cardiovascular events (MACE) | Cardiac death, any TV-MI, target vessel revascularization (TVR) and TLR in-hospital or at follow-up; | In Hospital and at follow-up (up to 5 years) | No |
Secondary | ST-segment resolution at the electrocardiogram (ECG) | ST-segment resolution at ECG within 60 minutes of primary PCI. | 60 minutes | No |
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