NCT02151929

Brief Summary

Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

May 22, 2014

Last Update Submit

May 30, 2014

Conditions

ST Elevation Acute Myocardial Infarction

Keywords

myocardial infarctionprimary PCIstent

Outcome Measures

Primary Outcomes (1)

  • Procedural and Clinical success

    Procedural success: The deployment of BVS at the intended target lesion with a final residual stenosis ≤20% and a TIMI 2-3 coronary flow by visual estimation without major periprocedural complication (death, emergent CABG, coronary perforation, flow limiting coronary dissection). Clinical success: any major in-hospital events (deaths, reinfarction, urgent revascularization, stroke, major bleedings)

    Patients will be followed for the duration of hospital stay (4-8 days)

Secondary Outcomes (1)

  • The MACE

    six months

Other Outcomes (1)

  • stent thrombosis

    six months

Study Arms (2)

Bioresorbable Vascular Scaffold

EXPERIMENTAL

Implantation of of an everolimus eluting bioresorbable scaffold in patients with STEMI treated with primary PCI

Device: Bioresorbable vascular scaffold

Everolimus Eluting stent

ACTIVE COMPARATOR

Implantation of of an everolimus eluting stent in patients with STEMI treated with primary PCI

Device: Everolimus eluting stent

Interventions

Bioresorbable vascular scaffoldDEVICE

stenting of an acute thrombotic lesion in patient within STEMI

Also known as: BVS, ABSORB (Abbot Vascular)
Bioresorbable Vascular Scaffold
Everolimus eluting stentDEVICE

stenting of an acute thrombotic lesion in patient within STEMI

Also known as: Xience Prime (Abbott Vascular)
Everolimus Eluting stent

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chest pain for more than 30 minutes;
  • ST-segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle-branch block

You may not qualify if:

  • Active internal bleeding or a history of bleeding diathesis within the previous 30 days;
  • Contraindication to dual antiplatelet therapy for 12 months;
  • Known allergy to everolimus;
  • A history of stroke within 30 days or any history of hemorrhagic stroke;
  • History, symptoms, or findings suggestive of aortic dissection;
  • High-likelihood of death within BVS resorbtion time;
  • Cardiogenic shock;
  • Infarct artery reference diameter, \<2.0 mm or \>3.7 mm (i.e. not suitable for currently available BVS sizes);
  • Pregnancy;
  • Participation in other trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology Ao Moscati

Avellino, 83100, Italy

Location

Related Publications (6)

  • Di Lorenzo E, Carbone G, Sauro L, Casafina A, Capasso M, Sauro R. Bare-metal stents versus drug-eluting stents for primary angioplasty: long-term outcome. Curr Cardiol Rep. 2011 Oct;13(5):459-64. doi: 10.1007/s11886-011-0207-0.

    PMID: 21792636BACKGROUND

  • De Luca G, Dirksen MT, Spaulding C, Kelbaek H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Diaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Cortese G, Suryapranata H, Stone GW; Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med. 2012 Apr 23;172(8):611-21; discussion 621-2. doi: 10.1001/archinternmed.2012.758.

    PMID: 22529227BACKGROUND

  • Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016.

    PMID: 19781402BACKGROUND

  • Di Lorenzo E, De Luca G, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G. The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial. JACC Cardiovasc Interv. 2009 Jun;2(6):515-23. doi: 10.1016/j.jcin.2009.03.012.

    PMID: 19539255BACKGROUND

  • Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.

    PMID: 18342684BACKGROUND

  • Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, Garcia-Garcia HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010 Nov 30;122(22):2301-12. doi: 10.1161/CIRCULATIONAHA.110.970772. Epub 2010 Nov 15.

    PMID: 21098436BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Emilio Di Lorenzo, MD PhD

    Division of Cardiology AO Moscati Avellino ITALY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dott. Emilio Di Lorenzo

Study Record Dates

First Submitted

May 22, 2014

First Posted

June 2, 2014

Study Start

May 1, 2013

Primary Completion

August 1, 2013

Study Completion

April 1, 2014

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

IT(1)