NCT02601781

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

October 16, 2015

Last Update Submit

December 28, 2016

Conditions

ST-elevation Myocardial Infarction (STEMI)

Keywords

Bioresorbable Vascular Scaffold (BVS)STEMIPrimary PCI

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Procedural Success

    0-7 days

  • Device oriented composite end-point (DOCE)

    6 months; 1, 3, 5 years

  • BVS Thrombosis

    In Hospital and at follow-up (up to 5 years)

  • Any Bleeding

    In Hospital and at follow-up (up to 5 years)

  • Major adverse cardiovascular events (MACE)

    In Hospital and at follow-up (up to 5 years)

  • +1 more secondary outcomes

Study Arms (1)

Primary PCI (PPCI) with BVS

EXPERIMENTAL

Primary percutaneous coronary intervention (PPCI) with bioresorbable vascular scaffold (BVS) implantation in STEMI patients. Following the arterial route, PPCI (performed according to the international guidelines) aims to recanalize an occluded coronary artery that is then maintained patent inserting an endovascular permanent prosthesis (stent). In this study we aim to assess the results following the use of a fully bioresorbable prosthesis (BVS) during PPCI using a pre-specified implantation strategy (eventual thrombectomy, intravascular imaging, lesion pre-dilatation, BVS implantation and BVS post-dilatation). BVS has the theoretical advantage, as compared with a permanent stent, to disappear within 24-36 months from implantation restoring the native pristine vessel state.

Procedure: Primary percutaneous coronary intervention (PPCI)Device: Bioresorbable Vascular Scaffold (BVS ABSORB)

Interventions

Primary percutaneous coronary intervention (PPCI)PROCEDURE

Primary percutaneous coronary intervention (PPCI) aims to recanalize an occluded coronary artery causing ST-elevation myocardial infarction (STEMI).

Primary PCI (PPCI) with BVS
Bioresorbable Vascular Scaffold (BVS ABSORB)DEVICE

BVS Use during Primary PCI following a pre-specified implantation strategy (eventual thrombectomy, intravascular imaging, lesion pre-dilatation, BVS implantation and BVS post-dilatation).

Primary PCI (PPCI) with BVS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset \<12 hours from hospital admission eligible for PPCI and BVS implantation;
  • Signed Patient Informed Consent/Data Release Form.

You may not qualify if:

  • Age \>75 years or \<18 years;
  • Cardiogenic shock;
  • Pregnancy or breastfeeding;
  • Infarct-artery max diameter (within planned device deployment segment) \<2.5 or \>3.7 mm;
  • Stent thrombosis/restenosis as a culprit lesion;
  • Acute occlusion of a saphenous vein graft as a culprit lesion;
  • Culprit lesion involving a bifurcation which requires a 2-stent strategy as intention-to-treat;
  • Culprit lesion involving a long diseased segment requiring hybrid (overlap BVS-DES) treatment;
  • Dialysis;
  • Comorbidities with life expectancy \<3 years;
  • Contraindication to 12 months dual anti-platelet therapy;
  • Severe calcification or/tortuosity in the segments proximal to the culprit lesion;
  • Absolute indication to chronic anticoagulation therapy;
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Division, Azienda Ospedaliera Bolognini Seriate

Seriate (BG), 24068, Italy

Location

Related Publications (6)

  • 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. 2017 Jun 1;89(7):1129-1138. doi: 10.1002/ccd.26801. Epub 2016 Oct 24.

    PMID: 27774758BACKGROUND

  • 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 Versus Everolimus-Eluting Stent in Primary Percutaneous Coronary Interventions. Am J Cardiol. 2015 Sep 1;116(5):705-10. doi: 10.1016/j.amjcard.2015.05.049. Epub 2015 Jun 3.

    PMID: 26100584RESULT

  • 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 scaffold implantation in patients with ST-segment myocardial infarction: insights from the multicentre "Registro ABSORB Italiano" (RAI registry). EuroIntervention. 2015 Jun;11(2):157-62. doi: 10.4244/EIJY14M10_11.

    PMID: 25354760RESULT

  • 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, Munzel T, Lee CH, Cequier A, Valdes M, Widimsky P, Serruys PW, Sabate M. Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):189-197. doi: 10.1016/j.jcin.2014.10.005.

    PMID: 25616924RESULT

  • Ielasi A, Campo G, Cortese B, Leoncini M, Varricchio A, Brugaletta S, Favaretto E, Fineschi M, Piraino D, Calabria P, Granata F, Pisano F, Mussardo M, Latib A, Tespili M. One-Year Results Following a Pre-Specified ABSORB Implantation Strategy in ST-Elevation Myocardial Infarction (BVS STEMI STRATEGY-IT Study). Cardiovasc Revasc Med. 2019 Aug;20(8):700-704. doi: 10.1016/j.carrev.2018.10.003. Epub 2018 Oct 4.

    PMID: 30314835DERIVED

  • Ielasi A, Campo G, Rapetto C, Varricchio A, Cortese B, Brugaletta S, Geraci S, Vicinelli P, Scotto di Uccio F, Secco GG, Poli A, Nicolini E, Ishida K, Latib A, Tespili M. A Prospective Evaluation of a Pre-Specified Absorb BVS Implantation Strategy in ST-Segment Elevation Myocardial Infarction: The BVS STEMI STRATEGY-IT Study. JACC Cardiovasc Interv. 2017 Sep 25;10(18):1855-1864. doi: 10.1016/j.jcin.2017.07.023.

    PMID: 28935077DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Alfonso Ielasi, MD

    Azienda Ospedaliera Bolognini di Seriate Bergamo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 16, 2015

First Posted

November 10, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2021

Last Updated

December 29, 2016

Record last verified: 2016-12

Locations

IT(1)