SORT OUT X - Combo Stent Versus ORSIRO Stent

NCT03216733 | Active Not Recruiting DMC

• 1 other identifier: 1-10-72-38-17
• Study Type: interventional
• Target: 3,148
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of the Danish Organisation for randomised trials with clinical outcome (SORT OUT) is to compare the safety and efficacy of the ComboTM stent and Orsiro™ stent in the treatment of unselected patients with ischemic heart disease, using registry detection of clinically driven events.

Conditions

Coronary Heart Disease; Angina Pectoris; Myocardial Infarction

Keywords

DES; Angina pectoris; Stent

Outcome Measures

Primary Outcomes (2)

• Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization

  Analysing the Kaplan-Meier method. Hazard ratios between groups will be calculated using a Cox proportional hazard model and the primary endpoint in the two per protocol treated groups will be compared with an upper one-sided 95% confidence interval. Patients treated with the OsiroTM stent will be used as the reference group

  Within 12 months

• Target Lesion Revascularisation (TLR)

  Repeat/new revascularization (PCI or CABG) within the stent or within a 5-mm border proximal or distal to the stent. (Angina, CCS \> 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR \<0.80, or iFR\< 0.90). TLR will be clinically driven.

  Within 12 months

Secondary Outcomes (8)

• Individual components of the primary end point comprise the secondary end points

  Clinical follow-up will be continued through 5 years

• Cardiac death

  Through 5 years

• MI

  Through 5 years

• Clinically indicated TLR

  Through 5 years

• All death

  Through 5 years

Study Arms (2)

COMBO

EXPERIMENTAL

PCI with COMBO stent

Device: COMBO

ORSIRO

ACTIVE COMPARATOR

PCI with ORSIRO stent

Device: ORSIRO

Interventions

COMBO DEVICE

PCI with COMBO stent

Also known as: Combined Sirolimus eluting and endothelial progenitor cell stent

COMBO

ORSIRO DEVICE

PCI with ORSIRO stent

Also known as: Sirolimus-eluting stent

ORSIRO

Eligibility Criteria

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

You may qualify if:

• All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at Rigshospitalet or one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study.
• The patients will be treated in accordance with the criteria applicable at the individual sites.
• The investigators plan to include 3,140 patients.

You may not qualify if:

• Age \< 18 years
• The patient does not wish to participate
• The patient is not able to consent to randomization (eg intubated patients)
• The patient do not speak Danish
• The patient is already included in this study
• The patient is already participating in other stent studies
• Life expectancy \<1 year
• Allergic to aspirin, clopidogrel, prasugrel or ticagrelor
• Allergic to sirolimus

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Biotronik SE & Co. KG: collaborator
• OrbusNeich: collaborator

Study Sites (4)

Aalborg University Hospital, Department of Cardiology

Aalborg, 9100, Denmark

Location

Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

Rigshospitalet, Hjertecentret

Copenhagen, 2100, Denmark

Location

Odense Unversity Hospital, Department of Cardiology

Odense C, 5000, Denmark

Location

Related Publications (3)

• Jakobsen L, Christiansen EH, Freeman P, Kahlert J, Veien K, Maeng M, Raungaard B, Ellert J, Villadsen AB, Kristensen SD, Christensen MK, Terkelsen CJ, Aaroe J, Thim T, Lassen JF, Hougaard M, Eftekhari A, Jensen RV, Stottrup NB, Rasmussen JG, Junker A, Jensen SE, Hansen HS, Jensen LO. Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial. EuroIntervention. 2023 Oct 23;19(8):676-683. doi: 10.4244/EIJ-D-23-00330.

  PMID: 37584207 DERIVED

• Jakobsen L, Christiansen EH, Freeman P, Kahlert J, Veien K, Maeng M, Raungaard B, Ellert J, Villadsen AB, Kristensen SD, Ahlehoff O, Christensen MK, Terkelsen CJ, Erik Botker H, Aaroe J, Thim T, Thuesen L, Aziz A, Eftekhari A, Jensen RV, Stottrup NB, Rasmussen JG, Junker A, Jensen SE, Hansen HS, Jensen LO. Randomized Clinical Comparison of the Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Combo Stent With the Sirolimus-Eluting Orsiro Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT X Trial. Circulation. 2021 Jun;143(22):2155-2165. doi: 10.1161/CIRCULATIONAHA.120.052766. Epub 2021 Apr 7.

  PMID: 33823606 DERIVED

• Jakobsen L, Christiansen EH, Maeng M, Kristensen SD, Botker HE, Terkelsen CJ, Madsen M, Raungaard B, Jensen SE, Christensen MK, Hansen HS, Jensen LO. Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent with the sirolimus-eluting Orsiro stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X trial. Am Heart J. 2018 Aug;202:49-53. doi: 10.1016/j.ahj.2018.04.019. Epub 2018 May 5.

  PMID: 29807307 DERIVED

MeSH Terms

Conditions

Coronary Disease; Angina Pectoris; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Lars Jakobsen, MD

  Aarhus University Hospital Skejby

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 13, 2017
• Study Start: June 1, 2017
• Primary Completion: November 30, 2018
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)