Study of Vascular Healing With the Combo Stent Versus the Everolimus Eluting Stent in ACS Patients by Means of OCT (REMEDEE-OCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405287
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : March 24, 2014
Genae associates
Information provided by (Responsible Party):

Brief Summary:

OBJECTIVE It is the objective of the REMEDEE OCT study to assess vascular healing after deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) in patients with Acute Coronary Syndrome (ACS) with single de novo native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.5 mm and ≤ 20 mm in length.

STUDY DESIGN The REMEDEE OCT study is a prospective, multicenter, randomized study designed to enroll 60 patients with ACS who will be randomized 1:1 to be treated with the Combo stent versus the commercially available everolimus eluting stent (Xience V or Promus). Patients will receive Optical Coherence Tomography (OCT) and Quatitative Coronary Angiography (QCA) follow-up imaging at 60 days post procedure. Clinical follow-up is scheduled at 30, 60, 180, 360 and 540 days. Furthermore, QCA and OCT will also be performed at baseline in all participants of the study.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Atherosclerosis Acute Coronary Syndrome (ACS) Myocardial Infarction (MI) Device: PTCA with stent placement Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study to Compare Vascular Healing After Deployment of the Abluminal Sirolimus Coated Bio-Engineered (Combo) Stent Versus the Everolimus Eluting Stent in Patients With Acute Coronary Syndrome by Means of OCT
Study Start Date : October 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Combo Stent
PTCA with Combo Stent
Device: PTCA with stent placement
PTCA with stent placement (Drug Eluting Stent)
Other Names:
  • Combo Stent
  • Xience V or Promus stent

Active Comparator: Everolimus Eluting Stent (EES)
PTCA with DES (Everolimus Eluting Stent: Xience V or Promus)
Device: PTCA with stent placement
PTCA with stent placement (Drug Eluting Stent)
Other Names:
  • Combo Stent
  • Xience V or Promus stent

Primary Outcome Measures :
  1. Percentage of uncovered stent struts per stent at follow-up (OCT) [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Secondary Clinical Endpoint: Major Adverse Cardiac Events (MACE) [ Time Frame: 30, 60, 180, 360, 540 days ]
    Major Adverse Cardiac Events (MACE)defined as a composite of death, Myocardial Infarction (MI) (Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG), or justified target lesion revascularization (TLR) by repeat Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Grafting (CABG) at hospital discharge

  2. Secondary Clinical Endpoint: components of MACE: cardiac death [ Time Frame: 30, 60, 180, 360, 540 days ]
    cardiac death

  3. Secondary Clinical Endpoints: components of MACE: MI [ Time Frame: 30, 60, 180, 360, 540 days ]
    MI (Q wave or non-Q wave)

  4. Secondary Clinical Endpoints: components of MACE: CABG or re-PTCA of target lesion [ Time Frame: 30, 60, 180, 360, 540 days ]
    emergent coronary artery bypass surgery (CABG), or clinically justified target lesion revascularization (TLR) by repeat PTCA or CABG at hospital discharge

  5. Secondary Clinical Endpoints: Stent thrombosis [ Time Frame: 30, 60, 180, 360, 540 days ]
    Target vessel stent thrombosis per Academic Research Consortium (ARC) definition

  6. Secondary OCT Endpoints (1/12) [ Time Frame: 60 days ]
    Percentage of stent strut malapposition

  7. Secondary OCT Endpoints (2/12) [ Time Frame: 60 days ]
    Maximum length of segments (mm) with uncovered struts

  8. Secondary OCT Endpoints (3/12) [ Time Frame: 60 days ]
    Maximum length of segments (mm) with malapposed struts

  9. Secondary OCT Endpoints (4/12) [ Time Frame: 60 days ]
    Maximum malapposition distance (mm)

  10. Secondary OCT Endpoints (5/12) [ Time Frame: 60 days ]
    Total malapposition volume

  11. Secondary OCT Endpoints (6/12) [ Time Frame: 60 days ]
    Maximal malapposition volume

  12. Secondary OCT Endpoints (7/12) [ Time Frame: 60 days ]
    Mean neointimal thickness (NIT)(strut level)

  13. Secondary OCT Endpoints (8/12) [ Time Frame: 60 days ]
    Percentage of protruding struts per stent

  14. Secondary OCT Endpoints (9/12) [ Time Frame: 60 days ]
    Frequency of Abnormal Intrastent Tissue (AIST)

  15. Secondary OCT Endpoints (10/12) [ Time Frame: 60 days ]
    Stent Volume

  16. Secondary OCT Endpoints (11/12) [ Time Frame: 60 days ]
    Lumen Volume

  17. Secondary OCT Endpoints (12/12) [ Time Frame: 60 days ]
    Neointimal Hyperplasia (NIH) Volume

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. age ≥18 and ≤ 80 years
  2. ST or Non-ST-segment elevation MI (assumed to be a type 1)
  3. Acceptable CABG candidate
  4. Patient willing to comply with specified follow-up
  5. Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent
  6. Single de novo or non-stented restenotic lesion in a native coronary artery
  7. Patients with 2-vessel coronary disease, may have undergone successful treatment (<20% diameter stenosis by visual estimate) of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment. Any non-target vessel or lesion intended to be treated during the index procedure or follow-up, cannot be an unprotected left main, ostial lesion, chronic total occlusion, heavily calcified, bifurcation, vein grafts, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty; 8. Target lesion (maximum length is 20 mm by visual estimate) to be covered by a single stent of max 23 mm (stent coverage incl at least 3 mm of healthy vessel is recommended). The lesion length to be measured after pre-dilation 9. Reference vessel diameter ≥2.5 to ≤ 3.5 mm by visual estimate 10. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected 11. Target lesion ≥50% and <100% stenosed by visual estimate

Exclusion Criteria

  1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
  2. Impaired renal function or on dialysis
  3. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC<3,000 cells/mm3
  4. Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
  5. Patient requires low molecular weight heparin (LMWH) treatment postprocedure or has received a dose of LMWH ≤8 hours prior to index procedure
  6. Patient has received any organ transplant or is on a waiting list for any organ transplant;
  7. Patient has other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (<1 year)
  8. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus and/or contrast sensitivity that cannot be adequately pre-medicated
  9. Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies
  10. Patient presents with cardiogenic shock
  11. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion;
  12. Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
  13. Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up
  14. Unprotected left main coronary artery disease with ≥50% stenosis
  15. Ostial target lesion(s)
  16. Totally occluded target vessel (TIMI flow 0)
  17. Calcified target lesion(s) which cannot be successfully predilated
  18. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
  19. Target lesion involving bifurcation with a side branch ≥2.0 mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require intervention of diseased side branch
  20. A significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single stent
  21. Diffuse distal disease to target lesion with impaired runoff
  22. Pre-treatment with devices other than balloon angioplasty
  23. Prior stent within 10 mm of target lesion
  24. Intervention (PCI or bypass) of any lesion in the target vessel performed within the previous 6 months
  25. Intervention (PCI or bypass) of another lesion in a non-target vessel performed within 30 days prior to the index
  26. Planned intervention of another lesion (target vessel or non-target vessel) within 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405287

OLV Ziekenhuis Aalst
Aalst, Belgium, 9300
AZ Middelheim
Antwerp, Belgium, 2020
Satakunta Central Hospital
Pori, Finland, 28500
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
University Hospital Zurich
Zurich, Switzerland, 8032
United Kingdom
King's College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Genae associates
Principal Investigator: Ulf Landmesser, MD, PhD University of Zurich

Responsible Party: OrbusNeich Identifier: NCT01405287     History of Changes
Other Study ID Numbers: VP-0509
36383 ( Other Identifier: CCMO )
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014

Keywords provided by OrbusNeich:
drug eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Acute Coronary Syndrome
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents