Overview

This trial is active, not recruiting.

Condition acute st segment elevation myocardial infarction
Treatment percutaneous coronary intervention
Phase phase 3
Sponsor ECRI bv
Collaborator Abbott Vascular
Start date December 2013
End date September 2015
Trial size 190 participants
Trial identifier NCT01986803, ECRI-003

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
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)
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.
(Active Comparator)
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)
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.

Primary Outcomes

Measure
Healing Score
time frame: 6 months follow-up

Secondary Outcomes

Measure
Procedure success
time frame: Study patients will be followed for the duration of hospital stay (e.g. until hospital discharge), an expected average of 2 days.
Device-Oriented Composite Endpoint
time frame: Up to 3 years
Cardiac Death
time frame: Up to 6 months
Cardiac Death
time frame: Up to 3 years
MI not clearly attributable to a non-intervention vessel
time frame: Up to 6 months
MI not clearly attributable to a non-intervention vessel
time frame: Up to 3 years
Clinically-indicated target lesion revascularization
time frame: Up to 6 months
Clinically-indicated target lesion revascularization
time frame: Up to 3 years
All-cause death at all timepoints
time frame: Up to 6 months
All-cause death at all timepoints
time frame: Up to 3 years
Any Myocardial Infarction at all timepoints
time frame: Up to 6 months
Any Myocardial Infarction at all timepoints
time frame: Up to 3 years
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints
time frame: Up to 6 months
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints
time frame: Up to 3 years
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints
time frame: Up to 6 months
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints
time frame: Up to 3 years
Scaffold/Stent thrombosis according to ARC definitions at all timepoints
time frame: Up to 6 months
Scaffold/Stent thrombosis according to ARC definitions at all timepoints
time frame: Up to 3 years
Angina Class at all timepoints
time frame: Up to 6 months
Angina Class at all timepoints
time frame: Up to 3 years
Other Serious Adverse Events at all timepoints
time frame: Up to 6 months
Other Serious Adverse Events at all timepoints
time frame: Up to 3 years
Device-Oriented Composite Endpoint
time frame: Up to 6 months
Percent diameter stenosis (%DS)
time frame: Up to 6-months
Minimal Lumen Diameter(MLD)
time frame: Up to 6-months
Late loss of the target lesion
time frame: Up to 6-months
Angiographic binary restenosis (ABR)
time frame: Up to 6-months
Presence of filling defect (%ILD)
time frame: 6-months
Presence of both malapposed and uncovered struts (%MN)
time frame: 6-months
Presence of uncovered struts alone(%N)
time frame: 6-months
Presence of malapposed struts alone(%M)
time frame: 6-months
Mean/minimal scaffold/stent diameter/area/volume
time frame: 6-months
Mean/minimal lumen diameter/area/volume
time frame: 6-months
Incomplete strut apposition (ISA) area/volume
time frame: 6-months
Percentage of covered struts
time frame: 6-months
Mean/maximal thickness of the struts coverage
time frame: 6-months
Neointimal hyperplasia area/volume
time frame: 6-months
Mean Flow area/volume
time frame: 6-months
Intraluminal defect area/volume
time frame: 6-months
Thickness of neointimal tissue developed over lipid rich plaque
time frame: 6-months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Comparison of the ABSORBTM Everolimus Eluting Bioresorbable Vascular Scaffold System With a Drug- Eluting Metal Stent (XienceTM) in Acute ST-Elevation Myocardial Infarction
Principal investigator P. Serruys, Prof.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by ECRI bv.