Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

NCT ID: NCT02151929

Last Updated: 2014-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-04-30

Brief Summary

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

Detailed Description

Background. Drug-eluting stent (DES) implantation may offer benefits in terms of repeat revascularization in patients with ST elevation myocardial infarction (STEMI). The everolimus eluting bioresorbable vascular scaffold (BVS) has shown efficacy and safety in stable patient but not in acute coronary syndromes. The study tested the feasibility and safety of BVS in patient treated with primary PCI (pPCI) Methods. Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary PCI capability will be randomly assigned to everolimus eluting stent (EES) or BVS. Primary endpoints are procedural and clinical success. The MACE (cardiac death, non fatal myocardial infarction, target lesion revascularization (TLR)) and definite or probable ST will be evaluated at six months.

Conditions

ST Elevation Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bioresorbable Vascular Scaffold

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

Group Type: EXPERIMENTAL

Bioresorbable vascular scaffold

Intervention Type: DEVICE

stenting of an acute thrombotic lesion in patient within STEMI

Everolimus Eluting stent

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

Group Type: ACTIVE_COMPARATOR

Everolimus eluting stent

Intervention Type: DEVICE

stenting of an acute thrombotic lesion in patient within STEMI

Interventions

Bioresorbable vascular scaffold

stenting of an acute thrombotic lesion in patient within STEMI

Intervention Type: DEVICE

Everolimus eluting stent

stenting of an acute thrombotic lesion in patient within STEMI

Intervention Type: DEVICE

Other Intervention Names

BVS, ABSORB (Abbot Vascular); Xience Prime (Abbott Vascular)

Eligibility Criteria

Inclusion Criteria

1. chest pain for more than 30 minutes;

2. ST-segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle-branch block

Exclusion Criteria

1. Active internal bleeding or a history of bleeding diathesis within the previous 30 days;

2. Contraindication to dual antiplatelet therapy for 12 months;

3. Known allergy to everolimus;

4. A history of stroke within 30 days or any history of hemorrhagic stroke;

5. History, symptoms, or findings suggestive of aortic dissection;

6. High-likelihood of death within BVS resorbtion time;

7. Cardiogenic shock;

8. Infarct artery reference diameter, <2.0 mm or >3.7 mm (i.e. not suitable for currently available BVS sizes);

9. Pregnancy;

10. Participation in other trials

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Giuseppe Moscati Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emilio Di Lorenzo MD PhD

Dott. Emilio Di Lorenzo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emilio Di Lorenzo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology AO Moscati Avellino ITALY

Locations

Division of Cardiology Ao Moscati

Avellino, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 21792636 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22529227 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19781402 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19539255 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18342684 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21098436 (View on PubMed)

Other Identifiers

AOM_BVS1

Identifier Type: -

Identifier Source: org_study_id