Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Combination Product: PCI with BioMatrix Alpha™ stent Combination Product: PCI with Combo™ stent | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 3140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Clinical Comparison of the Combined 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. |
Actual Study Start Date : | August 14, 2019 |
Estimated Primary Completion Date : | June 1, 2022 |
Estimated Study Completion Date : | November 30, 2030 |
Arm | Intervention/treatment |
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Active Comparator: Combo
PCI with COMBO stent
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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
Other Name: Combined sirolimus eluting and endothelial progenitor cell Combo™ stent
|
Active Comparator: BioMatrix Alpha
PCI with BioMatrix Alpha stent
|
Combination Product: 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
Other Name: Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
|
The acute MI diagnosis follows "The Joint ESC/ACCF/AHA/WHF Task Force on "Third Universal Definition of MI" (23), which has been adapted by Academy Research Consortium (22).
In cases of updates of the definition of MI, the latest definition will be used.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
Contact: Phillip Freemann, MD | +4597664457 | p.freeman@rn.dk | |
Contact: Leif Thuesen, MD | +4597664465 | leif.thuesen@rn.dk |
Denmark | |
Aarhus University Hospital, Skejby | Recruiting |
Aarhus, Denmark, 8200 | |
Contact: Evald H Christiansen, MD evald.christiansen@dadlnet.dk | |
Odense Unversity Hospital | Recruiting |
Odense, Denmark, 5000 | |
Contact: Lisette O Jensen, MD okkels@dadlnet.dk |
Principal Investigator: | Phillip Freemann, MD | Aalborg University Hospital |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 10, 2019 | ||||||||
First Posted Date ICMJE | May 16, 2019 | ||||||||
Last Update Posted Date | April 19, 2021 | ||||||||
Actual Study Start Date ICMJE | August 14, 2019 | ||||||||
Estimated Primary Completion Date | June 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent | ||||||||
Official Title ICMJE | Randomized Clinical Comparison of the Combined 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. | ||||||||
Brief Summary | SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease. | ||||||||
Detailed Description | 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 | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Coronary Artery Disease | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
3140 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | November 30, 2030 | ||||||||
Estimated Primary Completion Date | June 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
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:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Denmark | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03952273 | ||||||||
Other Study ID Numbers ICMJE | Sort Out XI | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Phillip Freeman, Aalborg University Hospital | ||||||||
Study Sponsor ICMJE | Phillip Freeman | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Aalborg University Hospital | ||||||||
Verification Date | April 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |