Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000623493
Ethics application status
Approved
Date submitted
30/11/2007
Date registered
5/12/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
COHEREX-EU:A Multi-Center Study to Evaluate the Safety and Efficacy of the Coherex FlatStent Patent Foramen Ovale(PFO) Closure System
Scientific title
A Feasibility study of 50 patients with symptomatic Patent ForamenOvale (PFO) undergoing closure of the defect using the Coherex FlatStent Patent Foramen Ovale (PFO) Closure System to evaluate the Safety and Efficacy of the device.
Universal Trial Number (UTN)
Trial acronym
COHEREX-EU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Patent Foramen Ovale 2597 0
The Coheres FlatStent Patemnt Foramen Oveale (PFO) Closure System will be implanted when closure of a Patent Foramen Ovale is clinically indicated. Each patient who receives an implant will be followed for six months after the the FlatStent is implanted. Enrollment will continue for six months or until 50 patients have been enrolled. 2600 0
Condition category
Condition code
Cardiovascular 2709 2709 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Coherex FlatStent Patent Foramen Ovale (PFO) Closure System is a implant placed percutaneously by an interventional cardioligist into a patent foramen ovale to close the congenital defect. Patients will be observed for 6 months post intervention.
Intervention code [1] 2330 0
Treatment: Devices
Intervention code [2] 2334 0
Treatment: Devices
Comparator / control treatment
No Comparator. This is a registry feasibility study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3607 0
1. The safety of the Coherex FlatStent PFO Closure System as measured by adverse events reported during and up to 30 days post procedure.
2. The efficacy of the Coherex FlatStent PFO Closure System as measured by the closure of the patent foramen ovale at 3 months.
Timepoint [1] 3607 0
1. Adverse event at 30days.
2. PFO closure at 90 days.
Secondary outcome [1] 6044 0
1. Adverse events at 3 and 6 months.
2. Procedural success defind as successful deployment and release of the Coheres FlatStent into the patient's PFO.
Timepoint [1] 6044 0
1. Patient follow-up at 3 and 6 months for a total post-procedure observation period of 6 months.
2. End of the procedure.

Eligibility
Key inclusion criteria
Patients between 18 and 65 years of age with a Patent Foramen Ovale and a clinical indication for closure of the PFO by percutaneous methods.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Candidates will be excluded from the study if ANY of the following conditions apply:
1. Patients with a contraindication and/or allergy to aspirin, Clopidrogel, Nitinol, Dacron polyurethane, nickel, stainless steel or other stent materials.
2. Patients allergic to intravenous (IV) contrast and any combination of drug allergies that would preclude adequate antiplatelet or alternative anticoagulant therapy.
2. Patients who have extensive congenital cardiac anomalies, which can only be adequately repaired by cardiac surgery.
3. Patients who have had a major stroke within the past 2 months or a minor stroke within the past two weeks.
4. Patients who require a trans-septal puncture to access the left atrium.
5. Patients who had sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
6. Patients who have demonstrated intracardiac thrombi on echocardiography.
7. Female patients who may be pregnant.
8. Patients with any active bacterial infection.
9. Patients with coronary disease or other structural heart disease.
10. Patients with known sustained arrhythmia.
11. Patients with any medical disorder or psychiatric illness that would interfere with the successful completion of the study.
12. Patients with any untreated medical problems that would interfere with the study.

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
Patients refered to investigators for PFO closure who meet inclusion/exclusion criteria will be invited to participate and be enrolled if the PFO sizes appropriate for the use of the Coherex FlatStent PFO Closure System.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 700 0
Germany
State/province [1] 700 0
Country [2] 701 0
New Zealand
State/province [2] 701 0

Funding & Sponsors
Funding source category [1] 2845 0
Commercial sector/Industry
Name [1] 2845 0
Coherex Medical Inc.
Country [1] 2845 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Coherex Medical Inc.
Address
3598 West 1820 South
Salt Lake City, Utah 84104
USA
Country
United States of America
Secondary sponsor category [1] 2565 0
None
Name [1] 2565 0
Address [1] 2565 0
Country [1] 2565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4790 0
Freiburger Ethik-Kommission International
Ethics committee address [1] 4790 0
Freiburger Ethik-Kommission International Mozartstrasse 21
79104 Freiburg
Germany
Ethics committee country [1] 4790 0
Germany
Date submitted for ethics approval [1] 4790 0
Approval date [1] 4790 0
27/09/2007
Ethics approval number [1] 4790 0
None

Summary
Brief summary
The COHEREX-EU Study is a multi-center registry of the first 50 patients to have their Patent Foramen Ovale closed with the Coheres FlatStent Patent Foramen Ovale (PFO) Closure System. This study will demonstrate the safety and efficacy of the Coheres FlatStent Patent Foramen Ovale (PFO) Closure System.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28221 0
Address 28221 0
Country 28221 0
Phone 28221 0
Fax 28221 0
Email 28221 0
Contact person for public queries
Name 11378 0
Randall K. Jones MD
Address 11378 0
3598 West 1820 South
Salt Lake City, Utah 84104
USA
Country 11378 0
United States of America
Phone 11378 0
(801)433-9900
Fax 11378 0
(801)433-9901
Email 11378 0
[email protected]
Contact person for scientific queries
Name 2306 0
Randall K. Jones MD
Address 2306 0
3598 West 1820 South
Salt Lake City, Utah 84104
USA
Country 2306 0
United States of America
Phone 2306 0
(801)433-9900
Fax 2306 0
(801)433-9901
Email 2306 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.