Stent Trial for Coarctaion of the Aorta to evaluate the safety and efficacy of the Large Diameter Advanta V12 Covered Stent for treatment of native and recurrent coartation of the aorta with primary endpoint being a significant reduction in the gradient across the coarctation at 12 months
- Conditions
- Patients with a presence of native or recurrent coarctation of the aortaCardiovascular - Normal development and function of the cardiovascular system
- Registration Number
- ACTRN12612000013864
- Lead Sponsor
- Atrium Medical Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria: - Patients with a presence of native or recurrent coarctation of the aorta as confirmed by blood pressure gradient, 2D-echocardiography with Doppler or angiography. - Subject weighs a minimum of 30 kg. - The peak pressure gradient is greater than or eqaul to 20 mmHg systolic blood pressure across the coarctation site. - Vessels at access site can accept a minimum size of 9 French for a 12 mm balloon and 11 French for a 14 and 16 mm balloon. - Coarctation can be successfully crossed with a guide wire, sheath and device. - Diameter of transverse arch distal to left subclavian artery is between 9.5 mm and 20 mm in diameter. - Subject is able and willing to adhere to all required follow-up visits and testing. - Subject is able and willing to adhere to the required follow-up medication regimen.
Exclusion Criteria: - The physician is not able to access the coarctation with standard techniques. - Presence of other thoracic aortic arterial lesions or aneurysms requiring treatment within 30 days of the implant procedure. - Length of coarctation is greater than 45 mm in length. - Connective tissue and genetic disorders, including William, Marfan, Turner, Noonan syndrome. - The coarctation has adjacent, acute thrombus. - The coarctation was previously treated with a stent. - Proximity of the coarctation to an important side branch resulting in crossing of the side branch with the Large Diameter Advanta V12 Covered Stent device (e.g. jailing of the branch vessel). - Subject has a tubular graft, interposition graft, stent graft at or near the coarctation site that would be interfere with delivery, positioning, expansion or stabilization of the Large Diameter Advanta V12 Covered Stent - Subject has contrast agent hypersensitivity that cannot be adequately premedicated, has a hypersensitivity to stainless steel, ePTFE or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications. - Bloodstream infection - Subject is pregnant or breastfeeding. - Subject has a co-morbid illness that may result in a life expectancy of less than 1 year. - The investigator deems the subject to be an inappropriate candidate for the study. - Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now approved product are not excluded by this criterion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A significant reduction in the gradient across the coarctation as assessed pre stent versus immediately post stent and pre stent vs. 12 month follow-up in two values from the Doppler echocardiographic profile: DV (diastolic velocity in cm/sec) and DV/SV (diastolic velocity /systolic velocity atio).[12 months];Morbidity rate (that is non-inferior to the surgery rate reported by Carr (The results of catheter based therapy compared with surgical repair of the adult aortic coarctation. J Am Coll Cardiol. 2006; 47: 1101-1107. ).[30 days]
- Secondary Outcome Measures
Name Time Method