NCT01254981

Brief Summary

To perform a randomized comparison between the Cypher Select+ stent and the Nobori stent in the treatment of unselected patients with ischaemic heart disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,504

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

1.5 years

First QC Date

December 6, 2010

Last Update Submit

August 28, 2013

Conditions

Coronary Artery DiseaseAngina Pectoris

Keywords

Percutaneous coronary interventionDESAngina pectorisStent

Outcome Measures

Primary Outcomes (1)

  • Primary outcome

    Major Adverse Cardiac Events, such as cardiac death, myocardial infarction, stent thrombosis or target lesion revascularisation: repeated revascularisation of an index lesion at PCI or bypass surgery

    Within 9 months

Secondary Outcomes (6)

  • Secondary outcome

  • Major Adverse Coronary Events

    30 days

  • Target lesion revascularisation defined as repeated revascularisation of an index lesion at PCI or bypass surgery.

    9 and 12 months and 3 years

  • Death

    30 days and 9 months

  • Acute Myocardial Infarction

    30 days and 9 months

  • +1 more secondary outcomes

Study Arms (2)

Nobori

EXPERIMENTAL

Percutaneous coronary intervention with implantation of coronary stent (Nobori)

Procedure: Percutaneous coronary intervention (PCI)

Cypher

EXPERIMENTAL

Percutaneous coronary intervention with implantation of coronary stent (Cypher)

Procedure: Percutaneous coronary intervention (PCI)

Interventions

Percutaneous coronary intervention (PCI)PROCEDURE

Implantation of coronary stent

Also known as: PCI, PTCA
CypherNobori

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients eligible for treatment with one or several drug-eluting coronary stents at one of the four heart centers in Odense, Skejby, Aalborg or Varde can be included in the study.
  • The patients will be treated in accordance with the criteria applicable at the individual sites. The indication for using DES varies slightly between the four sites, as the indication for implantation of DES is based on clinical and angiographic criteria with the financial constraints applying at the individual site. Basically, DES will be chosen instead of BMS in patients with an estimated increased risk of restenosis, in patients with the following stenosis types: Long lesions, lesions in small vessels, bifurcations, ostial lesions, in-stent restenoses and stenosis in the proximal segment of the anterior descending branch. Furthermore, DES will also be chosen for diabetics and in the left main.

You may not qualify if:

  • The patient does not wish to participate
  • The patient is participating in other randomized stent studies
  • Life expectancy \< 1 year
  • Allergic to Aspirin, clopidogrel, prasugrel or ticlopidin
  • Allergic to sirolimus or biolimus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • Christiansen EH, Jensen LO, Thayssen P, Tilsted HH, Krusell LR, Hansen KN, Kaltoft A, Maeng M, Kristensen SD, Botker HE, Terkelsen CJ, Villadsen AB, Ravkilde J, Aaroe J, Madsen M, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) V investigators. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial. Lancet. 2013 Feb 23;381(9867):661-9. doi: 10.1016/S0140-6736(12)61962-X. Epub 2013 Jan 30.

    PMID: 23374649DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAngina Pectoris

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Evald H Christiansen, MD

    Aarhus University Hospital Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. DMSc

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 7, 2010

Study Start

July 1, 2009

Primary Completion

January 1, 2011

Study Completion

December 1, 2011

Last Updated

August 29, 2013

Record last verified: 2013-08

Locations

DK(3)