Conor Cobalt Chromium Reservoir Based Stent With Sirolimus Elution in Native Coronary Artery Lesions

Coronary Disease Clinical Trial

— NEVO RES-II  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00714883
• Other study ID #: CP-07
• Status: Terminated
• Phase: Phase 2
• First received: July 10, 2008
• Last updated: October 24, 2012
• Start date: June 2008
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Ireland: Irish Medicines BoardGermany: Federal Institute for Drugs and Medical DevicesLatvia: State Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 2012
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Cordis Corporation	Conor Medsystems

Countries where clinical trial is conducted

Germany,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target lesion failure (TLF)		12 months post procedure	Yes
Secondary	Lesion success		Procedure	No