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

NCT00714883 | Terminated Phase 2 DMC

• 1 other identifier: CP-07
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Coronary Disease

Keywords

drug-eluting stents; Percutaneous coronary intervention (PCI)

Outcome Measures

Primary Outcomes (1)

• target lesion failure (TLF)

  12 months post procedure

Secondary Outcomes (1)

• Lesion success

  Procedure

Interventions

NEVO™ Sirolimus-eluting Coronary Stent System DEVICE

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.

Also known as: NEVO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cordis US Corp.: lead
• Conor Medsystems: collaborator

Study Sites (2)

Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes

Homburg/Saar, Germany

Location

P. Stradina Clinical - University Hospital

Riga, Latvia

Location

Related Publications (1)

• 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.

  PMID: 21386089 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Andrejs Erglis, MD

  P. Stradina Clinical-University Hospital

  PRINCIPAL INVESTIGATOR

• Prof. Bruno Scheller

  Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: October 1, 2012
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

DE (1); LA (1)