Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Denmark / NCT03952273
Active, not recruiting Not applicable

Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

NCT03952273 · tracked via the Priya Life Science Denmark tracker
Sponsor
Phillip Freeman
Phase
Not applicable
Started
2019-08-14
Last updated
2023-04-26

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

PCI with BioMatrix Alpha™ stentPCI with Combo™ stent

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

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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: * 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

Primary outcome measure(s)

  • Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization — Within 12 months
    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.
  • Target Lesion Revascularisation (TLR) — Within 12 months
    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.

Trial sites (2)

FacilityCityRegionStatus
Aarhus University Hospital, Skejby Aarhus Denmark
Odense Unversity Hospital Odense Denmark

Other trials for the same condition

VIsualization of Coronary Artery Disease for Modification of RISK Factors Active, not recruiting
The Nordic-Baltic Bifurcation Study IV Active, not recruiting
Electronic Letters to Improve Patient Activation in IHD: The NUDGE-IHD Trial Starting soon
Precise Procedural and PCI Plan (P4) Active, not recruiting
Personalized Evaluation of Susptected Myocardial Ischemia Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03952273 on ClinicalTrials.gov ↗ ← All trials in Denmark