ABSORB STEMI: the TROFI II Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-06

Study Completion Date

2017-09-21

Brief Summary

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This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority, European multicenter clinical trial.

The primary objective of this study is to assess the neointimal healing score (as evaluated by intra-coronary OFDI) in patients with ST-elevation Myocardial Infarction (STEMI) and treated with Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS) at 6 months follow-up by comparing with a metallic drug eluting stent (XIENCE). Furthermore, the safety and feasibility of implanting ABSORB BVS in patients with STEMI is assessed.

It is hypothesized that acutely and at 6 months follow-up implantation of the ABSORB fully bioresorbable everolimus-eluting scaffold is at least as safe as implantation of metallic drug-eluting stent, and that at late follow-up the ABSORB scaffold could improve the arterial healing process and potentially reduce late stent thrombosis in patients presenting with STEMI.

This is a preparatory trial in anticipation of a major outcome study.

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Detailed Description

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A total of 190 patients will be included in this trial, at 8-10 European sites.

The primary endpoint is arterial healing at 6 month follow up. To assess the arterial healing, at 6 months follow-up all patients will undergo angiographic follow-up with OFDI investigation. To score the arterial healing, a Healing Score is used.

Conditions

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Acute ST Segment Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PCI with ABSORBTM bioresorbable vascular scaffold system (BVS)

All patients assigned to the experimental arm will be treated with a primary Percutaneous Coronary Intervention using the Abbott Vascular ABSORB TM everolimus eluting bioresorbable vascular scaffold system (BVS)

Group Type EXPERIMENTAL

Percutaneous Coronary Intervention

Intervention Type DEVICE

Implanting a device ("Xience Xpedition" stent or "Abbott Vascular ABSORBTM everolimus eluting bioresorbable vascular scaffold system (BVS)" to open a diseased coronary artery by going to the coronary artery subcutaneously through the arteries from the radial or femoral artery access point.

PCI with XIENCE Xpedition stent

All patients assigned to the experimental arm will be treated with a primary Percutaneous Coronary Intervention using the XIENCE Everolimus Eluting Coronary Stent System (XIENCE Xpedition) (commercial product)

Group Type ACTIVE_COMPARATOR

Percutaneous Coronary Intervention

Intervention Type DEVICE

Implanting a device ("Xience Xpedition" stent or "Abbott Vascular ABSORBTM everolimus eluting bioresorbable vascular scaffold system (BVS)" to open a diseased coronary artery by going to the coronary artery subcutaneously through the arteries from the radial or femoral artery access point.

Interventions

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Percutaneous Coronary Intervention

Implanting a device ("Xience Xpedition" stent or "Abbott Vascular ABSORBTM everolimus eluting bioresorbable vascular scaffold system (BVS)" to open a diseased coronary artery by going to the coronary artery subcutaneously through the arteries from the radial or femoral artery access point.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject must be at least 18 years of age;
2. Primary PCI within 24 hours of symptom onset;
3. ST-segment elevation of \> 1mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \>1mm in \>2 contiguous anterior leads;
4. Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery within planned device deployment segment (Dmax) by visual estimation of ≥ 2.5 mm and ≤ 3.8 mm;
5. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 6 months following the index procedure.

Exclusion Criteria

1. Inability to provide informed consent;
2. Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization;
3. Known intolerance to aspirin, heparin, PLLA (poly(L-lactic acid), everolimus, contrast material;
4. Cardiogenic Shock;
5. Unprotected left main coronary artery stenosis;
6. Distal occlusion of target vessel;
7. Acute myocardial infarction secondary to stent thrombosis;
8. Mechanical complications of acute myocardial infarction;
9. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter;
10. Fibrinolysis prior to PCI;
11. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy;
12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No