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Use of BVS in ST-segment Elevation Myocardial Infarction (STEMI): the BVS STEMI STRATEGY-IT Prospective Registry

NCT02601781 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2016-12-29

No results posted yet for this study

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.

Conditions

  • ST-elevation Myocardial Infarction (STEMI)

Interventions

PROCEDURE

Primary percutaneous coronary intervention (PPCI)

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

DEVICE

Bioresorbable Vascular Scaffold (BVS ABSORB)

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

Sponsors & Collaborators

  • Azienda Ospedaliera Bolognini di Seriate Bergamo

    lead OTHER

Principal Investigators

  • Alfonso Ielasi, MD · Azienda Ospedaliera Bolognini di Seriate Bergamo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601781 on ClinicalTrials.gov