Conor Cobalt Chromium Reservoir Based Stent With Sirolimus Elution in Native Coronary Artery Lesions (NEVO RES-II)

This study has been terminated.
(The NEVO™ stent will not be commercialized. Cordis decided to close the study after 3 years. This decision took the absence of safety signals into account.)
Sponsor:
Collaborator:
Conor Medsystems
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00714883
First received: July 10, 2008
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Coronary Disease
Device: NEVO™ Sirolimus-eluting Coronary Stent System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • target lesion failure (TLF) [ Time Frame: 12 months post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lesion success [ Time Frame: Procedure ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: June 2008
Study Completion Date: October 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NEVO™ Sirolimus-eluting Coronary Stent System
    Intervention will consist of percutaneous coronary intervention for treatment of lesions in native coronary arteries using standard coronary intervention techniques. Intervention will include treatment with the NEVO™ Sirolimus-eluting Coronary Stent System.
    Other Name: NEVO
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714883

Locations
Germany
Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes
Homburg/Saar, Germany
Latvia
P. Stradina Clinical - University Hospital
Riga, Latvia
Sponsors and Collaborators
Cordis Corporation
Conor Medsystems
Investigators
Principal Investigator: Andrejs Erglis, MD P. Stradina Clinical-University Hospital
Principal Investigator: Prof. Bruno Scheller Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes
  More Information

No publications provided by Cordis Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00714883     History of Changes
Other Study ID Numbers: CP-07
Study First Received: July 10, 2008
Last Updated: October 24, 2012
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines

Keywords provided by Cordis Corporation:
drug-eluting stents
Percutaneous coronary intervention (PCI)

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Chromium
Sirolimus
Everolimus
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 20, 2014