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SORT-OUT V - Randomised Clinical Comparative Study of the Nobori and the Cypher Stent.

This study has been completed.
Sponsor:
Collaborators:
Terumo Europe N.V.
Johnson & Johnson
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT01254981
First received: December 6, 2010
Last updated: August 28, 2013
Last verified: August 2013

December 6, 2010
August 28, 2013
July 2009
January 2011   (final data collection date for primary outcome measure)
Primary outcome [ Time Frame: Within 9 months ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01254981 on ClinicalTrials.gov Archive Site
  • Secondary outcome [ Designated as safety issue: Yes ]
    • Device success rate defined as the frequency of a successful implantation of the study stent in all the stenoses scheduled to be treated with residual stenosis < 20
    • Procedural success rate defined as the frequency of successful implantation of the study stent in all the stenoses scheduled to be treated with residual stenosis < 20% and without serious complications (MACE = Major Adverse Coronary Events))
    • Procedural time defined as time from guiding catheter in to guiding catheter out
    • X-ray time
    • Use of contrast medium
  • Major Adverse Coronary Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Cardiac death, myocardial infarction, target vessel revascularisation: repeated revascularisation of an index lesion at PCI or bypass surgery
  • Target lesion revascularisation defined as repeated revascularisation of an index lesion at PCI or bypass surgery. [ Time Frame: 9 and 12 months and 3 years ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 30 days and 9 months ] [ Designated as safety issue: Yes ]
  • Acute Myocardial Infarction [ Time Frame: 30 days and 9 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Defined in accordance with the ARC definition of stent thrombosis
  • Secondary outcome [ Designated as safety issue: Yes ]
    • Device success rate defined as the frequency of a successful implantation of the study stent in all the stenoses scheduled to be treated with residual stenosis < 20
    • Procedural success rate defined as the frequency of successful implantation of the study stent in all the stenoses scheduled to be treated with residual stenosis < 20% and without serious complications (MACE = Major Adverse Coronary Events))
    • Procedural time defined as time from guiding catheter in to guiding catheter out
    • X-ray time
    • Use of contrast medium
  • Major Adverse Coronary Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Cardiac death, myocardiel infarction, target vessel revascularisation: repeated revascularisation of an index lesion at PCI or bypass surgery
  • Target lesion revascularisation defined as repeated revascularisation of an index lesion at PCI or bypass surgery. [ Time Frame: 9 and 12 months and 3 years ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 30 days and 9 months ] [ Designated as safety issue: Yes ]
  • Acute Myocardiel Infarction [ Time Frame: 30 days and 9 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Defined in accordance with the ARC definition of stent thrombosis
Not Provided
Not Provided
 
SORT-OUT V - Randomised Clinical Comparative Study of the Nobori and the Cypher Stent.
Randomized Clinical Comparative Study of the Nobori and the Cypher Stents in Unselected Subjects With Ischemic Heart Disease

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

All patients to be treated with one or several drug-eluting coronary stents at one of the four heart centers in Odense, Skejby, Aalborg and Varde can be included in the study. All patients enrolled in the study will be hospitalized at one of the heart centers mentioned. Patients will not be recruited via advertisements.

The study is designed as a non-inferiority study, where the objective is to prove that Nobori is Δ0 poorer as a maximum than Cypher select+. The nine-month event rate (cardiac death, MI and/or TVR) in the Cypher stent group of SORT OUT 3 was 3.0%

The calculation of power below has been made under the following assumptions:

P (Cypher) = 0.03

There is no good estimate for the event rate related to the Nobori stent. α = 0.05 - one-sided

1-β = 0.80

Based on the various values of Δ0 the necessary number of patients, N, in each group can be calculated (StudySize Version 2.0.4, Creostat):

  • Δ0 *N in each group
  • 0.0025 *57,589
  • 0.005 *14,397
  • 0.010 *3,599
  • 0.015 *1,599
  • 0.020 *900

According to the above assumptions, a total of 900 patients must be included in each group in order to reject a null hypothesis that the event rate in the Nobori group is more than 2 percentage points (0.02) poorer than the event rate in the Cypher group or that Nobori is inferior to Cypher, (H0: pNobori - pCypher ≥ Δ0 = 0.02). The alternative hypothesis (HA: pN - pS < Δ0) provides that Nobori is non-inferior to Cypher - with the selected limit for non-inferiority.

Assuming an inclusion rate of 200 patients per month, it will be possible to include 2000 patients in 10 months.

Power is almost 0.9 if the inclusion is increased to a little over 2400.

Organization

The study is headed by a steering committee, in which PCI operators will participate from each of the participating sites.

Evald Høj Christiansen, Aarhus, will be Principal Investigator. At present, the other members of the steering committee are: Jens Flensted Lassen (chairman), Leif Thuesen, Jan Ravkilde, Hans-Henrik Tilsted, Per Thayssen and Lisette Okkels Jensen. All members of the steering committee will be given full access to the database and will take part in the interpretation of data.

The study secretariat and the randomization computer are localized at the Department of Cardiology, [Hjertemedicinsk Afdeling], Aarhus University Hospital, Skejby.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Angina Pectoris
Procedure: Percutaneous coronary intervention (PCI)
Implantation of coronary stent
Other Names:
  • PCI
  • PTCA
  • Experimental: Nobori
    Percutaneous coronary intervention with implantation of coronary stent (Nobori)
    Intervention: Procedure: Percutaneous coronary intervention (PCI)
  • Experimental: Cypher
    Percutaneous coronary intervention with implantation of coronary stent (Cypher)
    Intervention: Procedure: Percutaneous coronary intervention (PCI)
Christiansen EH, Jensen LO, Thayssen P, Tilsted HH, Krusell LR, Hansen KN, Kaltoft A, Maeng M, Kristensen SD, Bøtker HE, Terkelsen CJ, Villadsen AB, Ravkilde J, Aarøe 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. PubMed PMID: 23374649.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2504
December 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01254981
M-20090103
Yes
Evald Hoej Christiansen, Aarhus University Hospital Skejby
Aarhus University Hospital Skejby
  • Terumo Europe N.V.
  • Johnson & Johnson
Principal Investigator: Evald H Christiansen, MD Aarhus University Hospital Skejby
Aarhus University Hospital Skejby
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP