Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000259549
Ethics application status
Approved
Date submitted
13/06/2006
Date registered
28/06/2006
Date last updated
18/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Drug Eluting Stent Intervention for Treating Side Branches Effectively
Scientific title
A prospective, multi center evaluation of the Bioliumus A9 eluting Axxess stent system in de novo coronary artery lesions. The study outcome will measure reduction in major adverse cardiac events compared to a historial control group.
Universal Trial Number (UTN)
Trial acronym
DIVERGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 1235 0
Condition category
Condition code
Cardiovascular 1320 1320 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study was originally designed to enroll 600 patients with de novo bifurcation lesions in native coronary arteries. The treatment will be single session stent implant with the Biolimus eluting Axxess stent system. Clinical follow up take place at 1, 6, 9 months, and annually for 5 years. Data will be compared to historical data set derived from the literature for patients treated with metal stents.

The study was modified to only enroll outside of the United States, therefore enrollment was limited to 300 study subjects. (The original study plan called for 300 OUS and 300 US.)
Intervention code [1] 1138 0
Treatment: Devices
Comparator / control treatment
No comparator.
Control group
Historical

Outcomes
Primary outcome [1] 1805 0
9 month composite Major Adverse Cardiac Events (Death, Myocardial Infarction, target lesion revascularization)
Timepoint [1] 1805 0
At 9 months
Secondary outcome [1] 3162 0
Angiographic restenosis
Timepoint [1] 3162 0
At 9 months.
Secondary outcome [2] 3163 0
Major Adverse Cardiac Events at 1 & 6 months, then annually for 5 years from date of procedure.
Timepoint [2] 3163 0
At 1 & 6 months, then annually for 5 years from date of procedure.

Eligibility
Key inclusion criteria
Suitable candidate for percutaneous transluminal coronary angioplasty (PTCA) and/or stentingLesion matches Duke University angiographic criteria for a bifurcaiton.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or women of childbearing potentialConcurrent MIDisease in more than two coronary arteriesRenal dysfunctionPrior stenting to target vesselUnable to comply with follow up procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
31/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 354 0
United States of America
State/province [1] 354 0

Funding & Sponsors
Funding source category [1] 1445 0
Commercial sector/Industry
Name [1] 1445 0
Devax, Inc.
Country [1] 1445 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Devax, Inc
Address
20995 Bake Parkway, Suite 106
Lake Forest, CA 92630
Country
United States of America
Secondary sponsor category [1] 1278 0
None
Name [1] 1278 0
none
Address [1] 1278 0
Country [1] 1278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5154 0
AZ Middelheim Hospital Ethics Committee
Ethics committee address [1] 5154 0
N/A
Ethics committee country [1] 5154 0
Belgium
Date submitted for ethics approval [1] 5154 0
05/03/2006
Approval date [1] 5154 0
02/05/2006
Ethics approval number [1] 5154 0
N/A

Summary
Brief summary
This study was originally planned to enroll 600 patients in a proscpective evaluation of a new stent developed for use in a special class of coronary artery blockages located at bifurcations. Bifurcations are lesions that occur just at the point where 1 vessel splits into two. Bifurcation lesions have been shown in the past to be difficult to treat with conventional stents and techniques. The study device is desigined specifically for these types of lesions. The study is designed to show that use of the new stent results in lower clinical event rates compared to a historical control group. Follow up will occur frequently in the first year (1, 6, 9 and 12 months), then annually for 5 years.

The study was modified to only include enrollment for the 300 subjects planned in Europe, Australia, and New Zealand. The 300 subjects that were planned for enrollment in the United States will instead be enrolled under a randomized trial as (newly) required by the US FDA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35844 0
Address 35844 0
Country 35844 0
Phone 35844 0
Fax 35844 0
Email 35844 0
Contact person for public queries
Name 10327 0
Brett Trauthen
Address 10327 0
13700 Alton Parkway
Irvine, California 92618
Country 10327 0
United States of America
Phone 10327 0
+1 949 461 0450 x39
Fax 10327 0
+1 949 541 0451
Email 10327 0
[email protected]
Contact person for scientific queries
Name 1255 0
Brett Trauthen
Address 1255 0
13700 Alton Parkway
Irvine California 92618
Country 1255 0
United States of America
Phone 1255 0
+1 949 461 0450 x39
Fax 1255 0
+1 949 541 0451
Email 1255 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.