Sirolimus Eluting ORSIRO Stent Versus Biolimus-eluting NOBORI Stent

NCT01879358 | Unknown DMC

• 2 other identifiers: SORT OUT VIIOUH
• Study Type: interventional
• Target: 2,314
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the sirolimus eluting ORSIRO stent and the biolimus-eluting NOBORI stent in a population-based setting, using registry detection of clinically driven events

Conditions

Coronary Artery Disease; Ischemic Heart Disease

Keywords

Drug-eluting stent; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• Cardiac death, myocardial infarction or target lesion revascularization

  Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization)

  12 months

Secondary Outcomes (1)

• Cardiac death, myocardial infarction, target lesion revascularization, target vessel revascularization, all cause mortality, stent thrombosis

  12 months

Study Arms (2)

ORSIRO stent

ACTIVE COMPARATOR

ORSIRO stent group

Device: Drug-eluting stent

NOBORI stent

ACTIVE COMPARATOR

NOBORI stent group

Device: Drug-eluting stent

Interventions

Drug-eluting stent DEVICE

Also known as: ORSIRO sirolimus-eluting stent, NOBORI biolimus-eluting stent

NOBORI stent; ORSIRO stent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent. There are no restrictions on number of treated lesions, number of treated vessels, or lesion length.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (5)

• Jensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, Villadsen AB, Junker A, Hansen KN, Kaltoft A, Maeng M, Pedersen KE, Kristensen SD, Botker HE, Ravkilde J, Sanchez R, Aaroe J, Madsen M, Sorensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV) Investigators. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012 Mar 13;125(10):1246-55. doi: 10.1161/CIRCULATIONAHA.111.063644. Epub 2012 Feb 3.

  PMID: 22308301 BACKGROUND

• Troan J, Christiansen EH, Hansen KN, Eftekhari A, Jakobsen L, Maeng M, Freeman P, Jensen RV, Christensen MK, Noori M, Ellert-Gregersen J, Stottrup NB, Kahlert J, Veien KT, Jensen LO. Five-year outcomes of patients with diabetes mellitus treated with a sirolimus-eluting or a biolimus-eluting stents with biodegradable polymer. From the SORT OUT VII trial. Diab Vasc Dis Res. 2024 Sep-Oct;21(5):14791641241283939. doi: 10.1177/14791641241283939.

  PMID: 39311502 DERIVED

• Hansen KN, Jensen LO, Maeng M, Christensen MK, Noori M, Kahlert J, Jakobsen L, Junker A, Freeman P, Ellert-Gregersen J, Raungaard B, Terkelsen CJ, Veien KT, Christiansen EH. Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial. Circ Cardiovasc Interv. 2023 Jan;16(1):e012332. doi: 10.1161/CIRCINTERVENTIONS.122.012332. Epub 2023 Jan 17.

  PMID: 36649389 DERIVED

• Jensen LO, Thayssen P, Maeng M, Ravkilde J, Krusell LR, Raungaard B, Junker A, Terkelsen CJ, Veien KT, Villadsen AB, Kaltoft A, Tilsted HH, Hansen KN, Aaroe J, Kristensen SD, Hansen HS, Jensen SE, Madsen M, Botker HE, Berencsi K, Lassen JF, Christiansen EH. Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT VII Trial. Circ Cardiovasc Interv. 2016 Jul;9(7):e003610. doi: 10.1161/CIRCINTERVENTIONS.115.003610.

  PMID: 27412869 DERIVED

• Jensen LO, Thayssen P, Maeng M, Ravkilde J, Hansen HS, Jensen SE, Botker HE, Berencsi K, Lassen JF, Christiansen EH. Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome VII trial. Am Heart J. 2015 Aug;170(2):210-5. doi: 10.1016/j.ahj.2015.05.009. Epub 2015 May 22.

  PMID: 26299216 DERIVED

Related Links

• SORT OUT IV with same clinically event driven methodology

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Jens F Lassen, MD DMSci

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD DMSci PhD

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: June 17, 2013
• Study Start: November 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2021
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

DK (1)