Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT01278303
Eligibility Criteria:
Inclusion Criteria: Inclusion criteria for use of a Covered CP Stent:
Native or recurrent aortic coarctation\* associated with ONE OR MORE of the following:
1. Acute or chronic aortic wall injury, or
2. Nearly atretic descending aorta to 3 mm or less in diameter, or
3. Genetic Syndromes associated with aortic wall weakening. Individuals with genetic syndromes such as Marfan Syndrome, Turner's Syndrome or familial bicuspid aortic valve and ascending aortic aneurysm
* The significance of aortic obstruction is left to the judgment of the participating investigator.
indications might include mild resting aortic obstruction associated with:
* Exercise related upper extremity hypertension;
* Severe coarctation with multiple and/or large arterial collaterals;
* Single ventricle physiology
* Left ventricular dysfunction
* Ascending aortic aneurysm
\+ Aortic wall injury might include:
* Descending aortic aneurysm
* Descending aortic pseudo-aneurysm
* Contained aortic wall rupture
* Non-contained rupture of the aortic wall
Exclusion Criteria:
1. Patient size too small for safe delivery of the device. The absolute lower limit for inclusion under this protocol is 20 kg. However, serious femoral artery injury can occur in small patients, particularly those in the 20-30 kg range and this risk must be reviewed in detail with parents or guardians of children in this weight range.
2. Planned deployment diameter less than 10 mm or greater than 22 mm
3. Location requiring covered stent placement across a carotid artery\*
4. Adults lacking capacity to consent
5. Pregnancy
* crossing or covering of a subclavian artery is acceptable in certain situations, but only after alternative treatments have been considered.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01278303
Study Brief:
Protocol Section:
NCT01278303