Status:
COMPLETED
Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth
Lead Sponsor:
OrbusNeich
Conditions:
Coronary Artery Disease
Coronary Artery Stenosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
This is a multi-center, prospective, non-randomized study. Approximately 90 patients from up to 16 centers will be entered in the study. Patients will be followed clinically for up to 5 years post-pro...
Detailed Description
Currently available coronary stents are prone to thrombosis and restenosis. It is believed that the accelerated re-establishment of a functional endothelial layer on damaged stented vascular segments ...
Eligibility Criteria
Inclusion
- 18 to 85 years of age;
- Symptomatic ischemic heart disease (CCS class 1-4, Braunwald class IB, IC, and/or objective evidence of myocardial ischemia);
- Treatment of 1 or 2 de novo lesions;
- Target lesion(s) is(are) located in a native coronary artery, which can be covered by one single stent of maximum 33 mm; The coronary artery lesion should be ≤27 mm in length (a margin of 3mm proximal and 3mm distal is recommended) and should be entirely covered by one single Genous Bio-engineered R stentTM . If predilation of the lesion is visually deemed necessary it should be performed prior to measuring the length of the lesion.
- Reference vessel diameter ≥ 2.5 and ≤ 3.75 mm by visual estimate;
- Acceptable candidate for coronary artery bypass surgery (CABG);
- Target lesion stenosis is ≥50% and \<100% (minimum TIMI flow I at the time of the PCI procedure) (visual estimate);
- The patient is willing to comply with the specified follow-up evaluation;
- The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Committee (EC).
Exclusion
- General exclusion criteria:
- Women who are pregnant or women of childbearing potential who do not use adequate contraception;
- A Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes or Troponin levels are less than twice the Upper Normal Limit;
- Impaired renal function (creatinine \> 3.0 mg/dl or 265 µmol/l);
- Any patient who has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3 or a WBC of \< 3,000 cells/mm3;
- Documented or suspected liver disease (including laboratory evidence of hepatitis);
- Recipient of heart transplant;
- Any patient who previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-murine Antibodies (HAMA);
- Patient with a life expectancy less than the follow-up period (5 years);
- Known allergies to aspirin, clopidogrel bisulphate (Plavix®) and ticlopidine (Ticlid®), heparin, or stainless steel;
- Known side-effects (clinically demonstrated by biological tests, elevated CK and liver assessments) to statins and previous attempts to treat side-effects were unsuccessful;
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
- Currently participating in an investigational drug or another device study that has not completed the primary endpoint, or subject to inclusion in another investigational drug or another device study during follow-up of this study;
- Patients currently undergoing chemotherapy or immunosuppressant therapy;
- Patients with known malignancy(ies).
- Angiographic exclusion criteria:
- Unprotected left main coronary artery disease with ≥ 50% stenosis;
- Ostial target lesion;
- Totally occluded target vessel (TIMI flow 0);
- Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
- Target lesion involves bifurcation class D \& type G including a side branch ≥ 2.5mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require stenting of diseased side branch;
- Angiographic evidence of thrombus in the target vessel;
- A significant (\> 50%) stenosis proximal or distal to the target lesion;
- Impaired runoff in the treatment vessel with diffuse distal disease;
- Ejection fraction ≤ 30%;
- Pre-treatment with devices other than balloon angioplasty, although direct stenting is allowed;
- Prior stent within 5mm of target lesion;
- Intervention of another lesion within 6 months before or within the scheduled angiographic follow-up of the index procedure.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00349895
Start Date
August 1 2006
End Date
January 1 2012
Last Update
April 8 2014
Active Locations (15)
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1
Medizinische Universitätsklinik
Graz, Austria, 8036
2
OLV Ziekenhuis Aalst
Aalst, Belgium, 9300
3
AZ Middelheim
Antwerp, Belgium, 2020
4
University Hospital Antwerp
Edegem, Belgium, 2650