None listed
Conditions
Brief summary
The primary objective is to evaluate the safety and efficacy of the Large Diameter Advanta V12 Covered Stent for treatment of native and recurrent aortic coarctation of the aorta in selected children and adolescents.
Interventions
Patients require transthoracic echocardiography and ECG to confirm eligibility. Eligible patients will undergo cardiac catheterisation to implant the stent into the thoracic aorta under general anaesthesia. Patients will undergo another echocardiogram at discharge, then at 6, 12, 24, 36, 48, and 60 months. A chest x-ray will be performed at 2 and 4 or 5 year follow up to evaluate the stent integrity.
Sponsors
Atrium Medical Corporation
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
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
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.
Outcome results
None listed