SORT-OUT VI - Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity®

Coronary Artery Disease Clinical Trial

— SO VI  

Official title:

Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® Coronary Stents in Non-selected Patients With Ischemic Heart Disease The SORT OUT VI Study*

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956448
• Other study ID #: M-20110037
• Status: Completed
• Phase: N/A
• First received: June 4, 2012
• Last updated: October 6, 2013
• Start date: March 2011
• Est. completion date: July 2012

Study information

• Verified date: October 2013
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.

Description:

SORT OUT VI is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the Biolimus-eluting Biomatrix Flex and the Zotarolimus-eluting Medtronic Resolute Integrity in treatment of atherosclerotic coronary artery lesions.

Primary Endpoint:

Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).

Secondary Endpoints:

Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).

Clinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2800
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent.

Exclusion Criteria:

• life expectancy of less than one year

• an allergy to aspirin, clopidogrel, ticagrelor, prasugrel, sirolimus, or biolimus

• participation in another randomized trial

• inability to provide written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Drug eluting stent
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Odense University Hospital	Odense
Denmark	Aarhus University Hospital	Skejby	Aarhus N

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Biosensors International, Medtronic Cardiovascular

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-related combined endpoint	Device-related combined endpoint hierarchically: cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion (new revascularization by PCI or CABG) within 12 months.	1,2,3 and 5 years	Yes
Secondary	Device success rate		12 months	Yes
Secondary	Procedure success rate		12 months	Yes
Secondary	Procedure time		12 months	No
Secondary	Fluoroscopy time		12 months	No
Secondary	Amount of contrast		12 months	No
Secondary	Combined endpoint of cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than target lesion, target lesion revascularisation		30 days	Yes
Secondary	Target lesion revascularisation		1,2,3 and 5 years	Yes
Secondary	Death and myocardial infarction		1 and 12 months	Yes
Secondary	Stent thrombosis		1,2,3 and 5 years	Yes
Secondary	Device-related combined endpoint hierarchically cardiac death, non-index procedure related AMI, not clearly related to another lesion than target lesion		2,3 and 5 years	Yes
Secondary	Patient-related combined endpoint hierarchically: all-cause death, non-index procedure related acute myocardial infarction, all new revascularizations		1,2,3 and 5 years	Yes
Secondary	All-cause death		10 years	Yes