Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct

NCT ID: NCT02067091

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2020-08-31

Brief Summary

Patients presenting with acute ST elevation myocardial infarct urgently need revascularization. Standard of care is establishing bloodflow through the coronary vessels using thrombus aspiration catheter, and securing the result by using a metallic drug eluting stent. New kinds of non-metallic bioresorbable stents are now available. They have however challenges in structural strength.

The investigators want to compare the new bioresorbable scaffold with traditional metallic stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120 patients. The investigators will use an imaging technique, optical coherence tomography, to evaluate the results after 12 months.

The investigators also want to see if modern multislice computed tomography can give useful information in the follow-up of stented coronary arteries after 12 and 24 months.

Detailed Description

Patients presenting with ST elevation myocardial infarction for primary PCI (percutaneous coronary intervention) will be screened. After thrombus aspiration, patient will be asked for oral consent if TIMI flow 2-3. Patient will then be randomized between drug eluting stent (Xience pro, Abbott Vascular Solutions) and bioresorbable scaffold (Absorb, Abbott Vascular Solutions). Optical coherence tomography (OCT) will be performed before stenting and after final result. Stent will be deployed without further predilatation if possible. Follow up at 12 months (clinical, angio with OCT and multislice CT coronary angiogram (MSCT-CA)) and 24 months (MSCT-CA).

Conditions

Acute ST Segment Elevation Myocardial Infarction

Study Design

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

Study Groups

BVS

Implantation of bioresorbable vascular scaffold in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention

Group Type: ACTIVE_COMPARATOR

stent implant in a coronary artery

Intervention Type: DEVICE

Implantation of device called a stent in a coronary artery

Percutaneous coronary intervention

DES

Implantation of drug eluting stent in coronary artery by direct stenting after thrombus aspiration by percutaneous coronary intervention

Group Type: ACTIVE_COMPARATOR

stent implant in a coronary artery

Intervention Type: DEVICE

Implantation of device called a stent in a coronary artery

Percutaneous coronary intervention

Interventions

stent implant in a coronary artery

Implantation of device called a stent in a coronary artery

Percutaneous coronary intervention

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. History of chest pain < 12 hrs

2. ST elevation of ≥ 2 mm in ≥2 contiguous precordial leads (V1-V6), and/or ≥ 1 mm in ≥ 2 contiguous standard leads (I, II, III, aVf, aVr,aVl).

3. Clinical decision to treat with primary PCI

4. > 18 years

5. Oral informed consent

Exclusion Criteria

1. Contraindications to long term double antiplatelet therapy

2. Known kidney failure with GFR < 45

3. Cardiac arrest or severe cardiogenic shock (Persistent BP <90 mmHg, despite adequate treatment)

4. Other severe illness with life expectancy of less than 12 months (eg. malignancy, severe malnutrition, degenerative disease)

Procedural contraindications:

1. Heavy calcification, tortuous vessel or large side branch (> 2,5 mm) at culprit lesion.

2. TIMI 0-1 flow after aspiration

3. Unable to advance thrombus aspiration catheter

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

Sponsors

Aarhus University Hospital Skejby

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

Feiring

UNKNOWN

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vegard Tuseth, PhD

Role: STUDY_CHAIR

University of Bergen

Jan Erik Nordrehaug, PhD

Role: STUDY_CHAIR

University of Bergen

Erlend Eriksen, MD

Role: PRINCIPAL_INVESTIGATOR

Helse-Bergen HF

Locations

Aarhus University Hospital, Skejby

Aarhus, , Denmark

Haukeland University Hospital

Bergen, , Norway

Countries

Denmark; Norway

Other Identifiers

2013/2006

Identifier Type: -

Identifier Source: org_study_id