Status:
COMPLETED
Study of Vascular Healing With the Combo Stent Versus the Everolimus Eluting Stent in ACS Patients by Means of OCT
Lead Sponsor:
OrbusNeich
Collaborating Sponsors:
Genae
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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)...
Detailed Description
BACKGROUND The implantation of bare-metal stents (BMS) has significantly reduced clinical and angiographic restenosis compared to balloon angioplasty alone after PCI due to eliminating elastic recoil ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
- Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up
- Unprotected left main coronary artery disease with ≥50% stenosis
- Ostial target lesion(s)
- Totally occluded target vessel (TIMI flow 0)
- Calcified target lesion(s) which cannot be successfully predilated
- Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
- 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
- A significant (\>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single stent
- Diffuse distal disease to target lesion with impaired runoff
- Pre-treatment with devices other than balloon angioplasty
- Prior stent within 10 mm of target lesion
- Intervention (PCI or bypass) of any lesion in the target vessel performed within the previous 6 months
- Intervention (PCI or bypass) of another lesion in a non-target vessel performed within 30 days prior to the index
- Planned intervention of another lesion (target vessel or non-target vessel) within 30 days.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01405287
Start Date
October 1 2011
End Date
January 1 2014
Last Update
March 24 2014
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
OLV Ziekenhuis Aalst
Aalst, Belgium, 9300
2
AZ Middelheim
Antwerp, Belgium, 2020
3
Satakunta Central Hospital
Pori, Finland, 28500
4
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ