Status:
COMPLETED
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
Lead Sponsor:
Atrium Medical Corporation
Conditions:
Coarctation of the Aorta
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in...
Detailed Description
The performance metric for comparison is based on data from the Congenital Cardiovascular Interventional Study Consortium (CCISC) as reported by Golden and Hellenbrand \[1\]. The CCISC experience from...
Eligibility Criteria
Inclusion
- 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 ≥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
- 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, expanded polytetrafluoroethylene (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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00978952
Start Date
September 1 2009
End Date
April 1 2017
Last Update
July 2 2017
Active Locations (9)
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1
The Children's Hospital at Westmead
Sydney, Australia, 2145
2
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil, 04012-180
3
Hospital for Sick Children Labatt Family Heart Centre
Toronto, Ontario, Canada, M5G 1X8
4
Heart Institute Berlin
Berlin, Germany