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Coronary DiseasePhase 2NEVO RES-IINCT00714883

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

A Phase 2 study testing NEVO™ Sirolimus-eluting Coronary Stent System in people with Coronary Disease, run by Cordis US Corp. at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Disease
What is being tested?
NEVO™ Sirolimus-eluting Coronary Stent System
Type of treatment
Medical device
How many people
3 participants
Where
2 sitesin 2 countries
Study dates
Jun 2008to Oct 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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);
Show all 21Show fewer
  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes

    Homburg/Saar

Other trials in Germany

Latvia1 site

  • P. Stradina Clinical - University Hospital

    Riga

Other trials in Latvia

About this study

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)

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

Being tested
NEVO™ Sirolimus-eluting Coronary Stent System
Keywords
drug-eluting stents, Percutaneous coronary intervention (PCI)
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEVO™ Sirolimus-eluting Coronary Stent SystemDevice

    Also called NEVO

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. target lesion failure (TLF)

    Measured: 12 months post procedure

Secondary outcomes (1)

  1. Lesion success

    Measured: Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionNov 2009
  4. Study completionOct 2012

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00714883
Sponsor's protocol ID
CP-07
Acronym
NEVO RES-II
Status last verified
Oct 2012
First submitted
10 Jul 2008
Last updated
25 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21386089

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NEVO™ Sirolimus-eluting Coronary Stent System in people with Coronary Disease, run by Cordis US Corp. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

target lesion failure (TLF) (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00714883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012.

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