COHEREX-EU:A Multi-Center Study to Evaluate the Safety and Efficacy of the Coherex FlatStent Patent Foramen Ovale(PFO) Closure System

Recruiting

• Conditions: Symptomatic Patent Foramen Ovale; 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.; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12607000623493
• Lead Sponsor: Coherex Medical Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The safety of the Coherex FlatStent PFO Closure System as measured by adverse events reported during and up to 30 days post procedure.<br>2. The efficacy of the Coherex FlatStent PFO Closure System as measured by the closure of the patent foramen ovale at 3 months.[1. Adverse event at 30days.<br>2. PFO closure at 90 days.]

Secondary Outcome Measures

Name	Time	Method
1. Adverse events at 3 and 6 months.<br>2. Procedural success defind as successful deployment and release of the Coheres FlatStent into the patient's PFO.[1. Patient follow-up at 3 and 6 months for a total post-procedure observation period of 6 months.<br>2. End of the procedure.]