Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 5 of 21 for:    abbott and absorb

ABSORB STEMI: the TROFI II Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Abbott Vascular
Terumo Europe N.V.
Information provided by (Responsible Party):
ECRI bv
ClinicalTrials.gov Identifier:
NCT01986803
First received: August 29, 2013
Last updated: January 12, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Acute ST Segment Elevation Myocardial Infarction
Device: Percutaneous Coronary Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ECRI bv:

Primary Outcome Measures:
  • Healing Score [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

    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".


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. Procedure success is no in-hospital Device Oriented Composite Endpoint, which is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.

  • Device-Oriented Composite Endpoint [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.

  • Cardiac Death [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  • Cardiac Death [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  • MI not clearly attributable to a non-intervention vessel [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  • MI not clearly attributable to a non-intervention vessel [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  • Clinically-indicated target lesion revascularization [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  • Clinically-indicated target lesion revascularization [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.

  • All-cause death at all timepoints [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint.

  • All-cause death at all timepoints [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint.

  • Any Myocardial Infarction at all timepoints [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint.

  • Any Myocardial Infarction at all timepoints [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint.

  • Non Ischemia-driven target lesion revascularization (TLR) at all timepoints [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint.

  • Non Ischemia-driven target lesion revascularization (TLR) at all timepoints [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint.

  • Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint.

  • Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint.

  • Scaffold/Stent thrombosis according to ARC definitions at all timepoints [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. ARC = academic research consortium

  • Scaffold/Stent thrombosis according to ARC definitions at all timepoints [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. ARC = academic research consortium

  • Angina Class at all timepoints [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. Angina Pectoris

  • Angina Class at all timepoints [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. Angina Pectoris

  • Other Serious Adverse Events at all timepoints [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint.

  • Other Serious Adverse Events at all timepoints [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical Endpoint.

  • Device-Oriented Composite Endpoint [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Clinical Endpoint. Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.

  • Percent diameter stenosis (%DS) [ Time Frame: Up to 6-months ] [ Designated as safety issue: No ]
    Angiographic endpoint. Percent diameter stenosis (%DS)at in in-segment (target lesion), in-device, proximal and distal

  • Minimal Lumen Diameter(MLD) [ Time Frame: Up to 6-months ] [ Designated as safety issue: No ]
    Angiographic endpoint. Minimal Lumen Diameter(MLD)at in in-segment (target lesion), in-device, proximal and distal

  • Late loss of the target lesion [ Time Frame: Up to 6-months ] [ Designated as safety issue: No ]
    Angiographic endpoint. Late loss (LL), which is decrease in blood vessel lumen diameter, at in in-segment (target lesion), in-device, proximal and distal

  • Angiographic binary restenosis (ABR) [ Time Frame: Up to 6-months ] [ Designated as safety issue: No ]
    Angiographic endpoint. Angiographic binary restenosis (ABR)at in in-segment (target lesion), in-device, proximal and distal

  • Presence of filling defect (%ILD) [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Presence of filling defect (%ILD), which is an individual component of the primary endpoint "Healing Score".

  • Presence of both malapposed and uncovered struts (%MN) [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Presence of both malapposed and uncovered struts (%MN)of the index stent, which is an individual component of the primary endpoint "Healing Score".

  • Presence of uncovered struts alone(%N) [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Presence of both uncovered struts of the index stent, which is an individual component of the primary endpoint "Healing Score".

  • Presence of malapposed struts alone(%M) [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Presence of both malapposed struts of the index stent, which is an individual component of the primary endpoint "Healing Score".

  • Mean/minimal scaffold/stent diameter/area/volume [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Mean/minimal scaffold/stent diameter/area/volume at 6-months follow-up.

  • Mean/minimal lumen diameter/area/volume [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Mean/minimal lumen diameter/area/volume at 6-months follow-up.

  • Incomplete strut apposition (ISA) area/volume [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Incomplete strut apposition (ISA) area/volume at 6-months follow-up.

  • Percentage of covered struts [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Percentage of covered struts at 6-months follow-up.

  • Mean/maximal thickness of the struts coverage [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Mean/maximal thickness of the struts coverage at 6-months follow-up.

  • Neointimal hyperplasia area/volume [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Neointimal hyperplasia area/volume at 6-months follow-up.

  • Mean Flow area/volume [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Mean Flow area/volume at 6-months follow-up.

  • Intraluminal defect area/volume [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Intraluminal defect area/volume at 6-months follow-up.

  • Thickness of neointimal tissue developed over lipid rich plaque [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    OFDI endpoint. Thickness of neointimal tissue developed over lipid rich plaque at 6-months follow-up.


Estimated Enrollment: 190
Study Start Date: December 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
Device: 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: 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)
Device: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986803

Locations
Denmark
Research centre Aarhus, DK003
Aarhus, Denmark
Research centre Odense, DK002
Odense, Denmark
Netherlands
Research centre Leeuwarden, NL002
Leeuwarden, Netherlands
Research centre Nieuwegein, NL014
Nieuwegein, Netherlands
Spain
Research centre Barcelona, ES001
Barcelona, Spain
Research centre Barcelona, ES003
Barcelona, Spain
Research centre Vigo, ES004
Vigo, Spain
Switzerland
Research centre Bern, CH006
Bern, Switzerland
Sponsors and Collaborators
ECRI bv
Abbott Vascular
Terumo Europe N.V.
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: ECRI bv
ClinicalTrials.gov Identifier: NCT01986803     History of Changes
Other Study ID Numbers: ECRI-003
Study First Received: August 29, 2013
Last Updated: January 12, 2015
Health Authority: Denmark: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee
Switzerland: Ethikkommission

Keywords provided by ECRI bv:
ST-elevation Myocardial Infarction (STEMI)
Primary Percutaneous Coronary Intervention within 24 hrs
Healing score
OFDI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Everolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015