Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

NCT ID: NCT03952273

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2030-11-30

Brief Summary

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

Detailed Description

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Randomized clinical comparison of the Sirolimus eluting and endothelial progenitor cell Combo™ stent and the Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent in patients treated with percutaneous coronary intervention

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combo

PCI with COMBO stent

Group Type ACTIVE_COMPARATOR

PCI with Combo™ stent

Intervention Type COMBINATION_PRODUCT

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

BioMatrix Alpha

PCI with BioMatrix Alpha stent

Group Type ACTIVE_COMPARATOR

PCI with BioMatrix Alpha™ stent

Intervention Type COMBINATION_PRODUCT

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

Interventions

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PCI with BioMatrix Alpha™ stent

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

Intervention Type COMBINATION_PRODUCT

PCI with Combo™ stent

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent Combined sirolimus eluting and endothelial progenitor cell Combo™ stent

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

OrbusNeich

INDUSTRY

Sponsor Role collaborator

Biosensors International

OTHER

Sponsor Role collaborator

Phillip Freeman

OTHER

Sponsor Role lead

Responsible Party

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Phillip Freeman

Principal Investigator, MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Phillip Freemann, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

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Aarhus University Hospital, Skejby

Aarhus, , Denmark

Site Status

Odense Unversity Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 40406942 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39870125 (View on PubMed)

Other Identifiers

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Sort Out XI

Identifier Type: -

Identifier Source: org_study_id

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