Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

NCT03952273 | Active Not Recruiting DMC

• 1 other identifier: Sort Out XI
• Study Type: interventional
• Target: 3,141
• Locations: 1 country
• Sites: 2

Brief Summary

SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.

Conditions

Coronary Artery Disease

Keywords

Drug eluting stent; 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

  The primary endpoint will be analyzed using 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 ComboTM 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

• Number of participants with Cardiac Death

  Through 5 years

• Number of participants with Myocardial Infarction

  Through 5 years

• Target Lesion Revascularization due to clincal symptoms

  Through 5 years

• Number of patients with all cause mortality

  Through 5 years

Study Arms (2)

Combo

ACTIVE COMPARATOR

PCI with COMBO stent

Combination Product: PCI with Combo™ stent

BioMatrix Alpha

ACTIVE COMPARATOR

PCI with BioMatrix Alpha stent

Combination Product: PCI with BioMatrix Alpha™ stent

Interventions

PCI with BioMatrix Alpha™ stent COMBINATION_PRODUCT

Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent

Also known as: Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent

BioMatrix Alpha

PCI with Combo™ stent COMBINATION_PRODUCT

Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent

Also known as: Combined sirolimus eluting and endothelial progenitor cell Combo™ stent

Combo

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 one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study.

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 the SORT OUT XI study
• Life expectancy \<1 year
• Allergic to study related treatment

Sponsors & Collaborators

• Phillip Freeman: lead
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• OrbusNeich: collaborator
• Biosensors International: collaborator

Study Sites (2)

Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Odense Unversity Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

• Eftekhari A, Jensen LO, Veien K, Raungaard B, Rasmussen JG, Maeng M, Terkelsen CJ, Ellert-Gregersen J, Stottrup NB, Lassen JF, Hansen HS, Thim T, Jensen RV, Nielsen R, Jensen SE, Kristensen SD, Hougaard M, Junker A, Christensen MK, Aaroe J, Froslev T, Jakobsen L, Christiansen EH. Biolimus-Eluting Biomatrix Stent vs a Dual-Therapy Sirolimus-Eluting Stent in PCI: The SORT OUT XI Randomized Trial. J Am Coll Cardiol. 2025 Jul 15;86(2):106-115. doi: 10.1016/j.jacc.2025.05.012. Epub 2025 May 21.

  PMID: 40406942 DERIVED

• Eftekhari A, Christiansen EH, Lassen JF, Raungaard B, Jakobsen L, Jensen LO. Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell combo Stent vs. biolimus eluting absorbable polymer coated biomatrix alpha stent in patients undergoing percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for randomized trials with clinical outcome (SORT OUT) XI trial. Am Heart J. 2025 May;283:37-42. doi: 10.1016/j.ahj.2025.01.012. Epub 2025 Jan 25.

  PMID: 39870125 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Phillip Freemann, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 16, 2019
• Study Start: August 14, 2019
• Primary Completion: March 19, 2023
• Study Completion (Estimated): November 30, 2030
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)