ABSORB STEMI: the TROFI II Study

NCT01986803 | Completed DMC

• 1 other identifier: ECRI-003
• Study Type: interventional
• Target: 191
• Locations: 4 countries
• Sites: 8

Brief 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.

Conditions

Acute ST Segment Elevation Myocardial Infarction

Keywords

ST-elevation Myocardial Infarction (STEMI); Primary Percutaneous Coronary Intervention within 24 hrs; Healing score; OFDI

Outcome Measures

Primary Outcomes (1)

• Healing Score

  The primary endpoint is: Healing Score at 6 months follow-up. This is measured with OFDI imaging. This Healing Score is a weighted index that combines the following parameters: 1. Presence of filling defect (%ILD) is assigned weight of "4", 2. Presence of both malapposed and uncovered struts (%MN) is assigned a weight of "3", 3. Presence of uncovered struts alone (%N) is assigned a weight of "2" and finally, 4. Presence of malapposition alone (%M) is assigned a weight of "1".

  6 months follow-up

Secondary Outcomes (40)

• Procedure success

  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

  Up to 3 years

• Cardiac Death

  Up to 6 months

• Cardiac Death

  Up to 3 years

• MI not clearly attributable to a non-intervention vessel

  Up to 6 months

Study Arms (2)

PCI with ABSORBTM bioresorbable vascular scaffold system (BVS)

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)

Device: Percutaneous Coronary Intervention

PCI with XIENCE Xpedition stent

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)

Device: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention 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 ABSORBTM bioresorbable vascular scaffold system (BVS); PCI with XIENCE Xpedition stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age;
• Primary PCI within 24 hours of symptom onset;
• 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;
• 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;
• Subject agrees to not participate in any other investigational or invasive clinical study for a period of 6 months following the index procedure.

You may not qualify if:

• Inability to provide informed consent;
• Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization;
• Known intolerance to aspirin, heparin, PLLA (poly(L-lactic acid), everolimus, contrast material;
• Cardiogenic Shock;
• Unprotected left main coronary artery stenosis;
• Distal occlusion of target vessel;
• Acute myocardial infarction secondary to stent thrombosis;
• Mechanical complications of acute myocardial infarction;
• 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;
• Fibrinolysis prior to PCI;
• Active bleeding or coagulopathy or patients at chronic anticoagulation therapy;
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Sponsors & Collaborators

• ECRI bv: lead
• Abbott Medical Devices: collaborator
• Terumo Europe N.V.: collaborator

Study Sites (8)

Research centre Aarhus, DK003

Aarhus, Denmark

Location

Research centre Odense, DK002

Odense, Denmark

Location

Research centre Leeuwarden, NL002

Leeuwarden, Netherlands

Location

Research centre Nieuwegein, NL014

Nieuwegein, Netherlands

Location

Research centre Barcelona, ES001

Barcelona, Spain

Location

Research centre Barcelona, ES003

Barcelona, Spain

Location

Research centre Vigo, ES004

Vigo, Spain

Location

Research centre Bern, CH006

Bern, Switzerland

Location

Related Publications (2)

• Cassese S, Katagiri Y, Byrne RA, Brugaletta S, Alfonso F, Raber L, Maeng M, Iniguez A, Kretov E, Onuma Y, Joner M, Sabate M, Laugwitz KL, Windecker S, Kastrati A, Serruys PW. Angiographic and clinical outcomes of STEMI patients treated with bioresorbable or metallic everolimus-eluting stents: a pooled analysis of individual patient data. EuroIntervention. 2020 Mar 20;15(16):1451-1457. doi: 10.4244/EIJ-D-18-01080.

  PMID: 30719976 DERIVED

• Yamaji K, Brugaletta S, Sabate M, Iniguez A, Jensen LO, Cequier A, Hofma SH, Christiansen EH, Suttorp M, van Es GA, Sotomi Y, Onuma Y, Serruys PW, Windecker S, Raber L. Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy. JACC Cardiovasc Interv. 2017 Sep 25;10(18):1867-1877. doi: 10.1016/j.jcin.2017.07.035.

  PMID: 28935079 DERIVED

Related Links

• Primary endpoint manuscript (PUBMED ID: 26405232)

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• P. Serruys, Prof.

  Erasmus Medical Centre Rotterdam, the Netherlands

  PRINCIPAL INVESTIGATOR

• M. Sabaté, Dr.

  University of Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• S. Windecker, Dr.

  Bern University Hospital, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: November 19, 2013
• Study Start: January 6, 2014
• Primary Completion: April 13, 2015
• Study Completion: September 21, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

CH (1); DK (2); NL (2); ES (3)