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

October 24, 2012 updated by: Cordis Corporation

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Homburg/Saar, Germany
        • Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes
  • Latvia
      • Riga, Latvia
        • P. Stradina Clinical - University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
target lesion failure (TLF)
Time Frame: 12 months post procedure
12 months post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Lesion success
Time Frame: Procedure
Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cordis Corporation

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 10, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (Estimate)

July 14, 2008

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

October 24, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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