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

NCT01405287 | Completed Phase 2 DMC

• 2 other identifiers: VP-050936383
• Study Type: interventional
• Target: 60
• Locations: 5 countries
• Sites: 6

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.

Conditions

Coronary Artery Disease; Atherosclerosis; Acute Coronary Syndrome (ACS); Myocardial Infarction (MI)

Keywords

stent; drug eluting stent; healing; endothelium; DES; OCT; MI; ACS

Outcome Measures

Primary Outcomes (1)

• Percentage of uncovered stent struts per stent at follow-up (OCT)

  60 days

Secondary Outcomes (17)

• Secondary Clinical Endpoint: Major Adverse Cardiac Events (MACE)

  30, 60, 180, 360, 540 days

• Secondary Clinical Endpoint: components of MACE: cardiac death

  30, 60, 180, 360, 540 days

• Secondary Clinical Endpoints: components of MACE: MI

  30, 60, 180, 360, 540 days

• Secondary Clinical Endpoints: components of MACE: CABG or re-PTCA of target lesion

  30, 60, 180, 360, 540 days

• Secondary Clinical Endpoints: Stent thrombosis

  30, 60, 180, 360, 540 days

Study Arms (2)

Combo Stent

EXPERIMENTAL

PTCA with Combo Stent

Device: PTCA with stent placement

Everolimus Eluting Stent (EES)

ACTIVE COMPARATOR

PTCA with DES (Everolimus Eluting Stent: Xience V or Promus)

Device: PTCA with stent placement

Interventions

PTCA with stent placement DEVICE

PTCA with stent placement (Drug Eluting Stent)

Also known as: Combo Stent, Xience V or Promus stent

Combo Stent; Everolimus Eluting Stent (EES)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 and ≤ 80 years
• ST or Non-ST-segment elevation MI (assumed to be a type 1)
• Acceptable CABG candidate
• Patient willing to comply with specified follow-up
• 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
• Single de novo or non-stented restenotic lesion in a native coronary artery
• 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

You may not qualify if:

• 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
• Impaired renal function or on dialysis
• Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC\<3,000 cells/mm3
• Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
• Patient requires low molecular weight heparin (LMWH) treatment postprocedure or has received a dose of LMWH ≤8 hours prior to index procedure
• Patient has received any organ transplant or is on a waiting list for any organ transplant;
• 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)
• 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
• Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies
• Patient presents with cardiogenic shock
• Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion;
• Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
• Unprotected left main coronary artery disease with ≥50% stenosis
• Ostial target lesion(s)
• Totally occluded target vessel (TIMI flow 0)

Sponsors & Collaborators

• OrbusNeich: lead
• Genae: collaborator

Study Sites (6)

OLV Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

AZ Middelheim

Antwerp, 2020, Belgium

Location

Satakunta Central Hospital

Pori, 28500, Finland

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

University Hospital Zurich

Zurich, 8032, Switzerland

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

• Jaguszewski M, Aloysius R, Wang W, Bezerra HG, Hill J, De Winter RJ, Karjalainen PP, Verheye S, Wijns W, Luscher TF, Joner M, Costa M, Landmesser U. The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis. JACC Cardiovasc Interv. 2017 Mar 13;10(5):489-499. doi: 10.1016/j.jcin.2016.11.040.

  PMID: 28279316 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Ulf Landmesser, MD, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 29, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: January 1, 2014
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

CH (1); BE (2); FI (1); GB (1); NL (1)