Clinical trial NCT00714883: Conor Cobalt Chromium Reservoir Based Stent With Sirolimus Elution in Native Coronary Artery Lesions
Official title: A Prospective, Multi-Center Study of the Conor Cobalt Chromium Reservoir Based Stent (NevoTM) With Sirolimus Elution in Native Coronary Artery Lesions (NEVO RES-II)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Coronary Disease
Keywords: drug-eluting stents
Percutaneous coronary intervention (PCI)
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
Collaborators: name: Conor Medsystems
First posted: 2008-07-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the target lesion failure rate of the NEVO Sirolimus-eluting Coronary Stent System.


Eligibility criteria: Inclusion Criteria:

* Subjects with atherosclerotic CAD ;
* The subject must be \>/= 18 years of age;
* Female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment;
* Diagnosis of angina pectoris as defined by stable angina pectoris Canadian Cardiovascular Society Classification (Class I, II, III) OR non-ST segment elevation acute coronary syndrome (Braunwald Classification B\&C) OR OR non-ST segment elevation myocardial infarction ≥ 48 hours from the time of study index procedure OR asymptomatic subjects with a positive stress test;
* Indicated treatment of up to two lesions in one or two major coronary arteries (1 target lesion in each of 2 vessels or 2 target lesions in 1 vessel). The target vessel diameter must be \>/= 2.25mm and \</= 3.5 in diameter (visual estimate);
* Target lesion length \</= 28 mm able to be treated with a single stent. If required, additional Conor Sirolimus stents should be used to treat dissections, etc
* Patient or Legally Authorized Representative must provide written informed consent prior to the procedure using a form that is approved by the Independent Ethics Committee.
* The patient is willing to comply with all specified follow-up evaluations.
* The target lesion has been successfully crossed with the intracoronary guidewire which is positioned intraluminally in the distal vessel.
* The target lesion diameter stenosis is \>50% and \<100% based on a visual estimate.

Exclusion Criteria:

* ST-elevation MI within 72 hours prior to the index procedure and/or creatine kinase (CK) \>2 times the local laboratory upper limits of normal on the day of the index procedure.
* The patient has undergone target vessel revascularization within 6 months prior to the intended enrolment procedure.
* Prior stent within 5 mm of target lesion(s);
* Ostial target lesion(s);
* Unprotected left main coronary disease with \>/= 50% stenosis;
* Angiographic evidence of thrombus within target lesion(s);
* Total coronary occlusion or TIMI grade 0 or 1 in the target vessel;
* Bifurcation disease involving a side branch \>/= 2 mm in diameter;
* Target lesion(s) within a coronary bypass graft (e.g., saphenous vein or arterial graft);
* Significant calcification or angulation in the target vessel that, in the Investigator's opinion, may preclude stent delivery and deployment;
* Recipient of heart transplant;
* Subject with a life expectancy less than 12 months;
* Known allergies to the following: aspirin, any thienopyridine, heparin, cobalt chromium, contrast agent (that cannot be managed medically), or sirolimus that cannot be managed medically;
* The patient has contraindication to ASA or to any thienopyridine agent.
* Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints;
* Known bleeding or hypercoagulable disorder;
* Known or suspected active infection at the time of the study procedures;
* Subject is known to be a prisoner, mentally incompetent, and/or alcohol or drug abuser;
* Subject has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study, or planned coronary PCI through the end of the study.
* The patient is currently taking systemic immunosuppressant therapy;
* The patient has co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.

Primary outcomes:
measure: target lesion failure (TLF)
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Lesion success
timeFrame: Procedure
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes
city: Riga
country: Latvia
facility: P. Stradina Clinical - University Hospital
Study officials:
affiliation: P. Stradina Clinical-University Hospital
name: Andrejs Erglis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes
name: Prof. Bruno Scheller
role: PRINCIPAL_INVESTIGATOR
References:
citation: Otake H, Honda Y, Courtney BK, Shimohama T, Ako J, Waseda K, Macours N, Rogers C, Popma JJ, Abizaid A, Ormiston JA, Spaulding C, Cohen SA, Fitzgerald PJ. Intravascular ultrasound results from the NEVO ResElution-I trial: a randomized, blinded comparison of sirolimus-eluting NEVO stents with paclitaxel-eluting TAXUS Liberte stents in de novo native coronary artery lesions. Circ Cardiovasc Interv. 2011 Apr 1;4(2):146-54. doi: 10.1161/CIRCINTERVENTIONS.110.957175. Epub 2011 Mar 8.