Follow Up of and Continued Access to Covered Cheatham-Platinum Stent for Prevention or Treatment of Aortic Wall Injuries Associated with Aortic Coarctation (COAST II)
The study is a prospective, multi-center, single-arm trial. The primary efficacy outcome is a comparison of severity of illness prior to and one year following stent implantation; each patient will serve as his or her own control. The surgical comparison for the primary safety outcome is derived from the literature, as described in Section Vi. H of the main protocol.
This study includes all patients, regardless of age or sex, with native or recurrent coarctation of the aorta and one or more of the conditions listed on pages 31-32 of the protocol.
it has been proposed to include in this trial patients who have been treated with Covered CP stents and followed prospectively at a CoaST iDe center. The CoaST follow-up protocol is as rigorous as the one proposed here for the new trial (CoaST ii), and site monitoring with source data verification will be performed. Patients have been managed and are being followed in the same manner as upcoming patients. These patients will be entered into the new, CoaST ii trial without bias and are referred to as legacy patients. all eligible legacy patients, regardless of outcome, will be included. The DSMB has reviewed all but the most recent cases. once the eligible legacy patients are enrolled in to CoaST ii, the DSMB will review the adverse event occurrences for these cases and provide a final classification. The local sites include minors age 5 to adults.
We propose continued access to the Covered CP Stent for another 30 patients. The Trial sites will be allowed to maintain a stock of these premounted stents to serve as an emergency supply for back up of routine and continued access CP Stent aortic interventions that result in aortic wall injury. Patients can also be prospectively [Quote]enrolled[Quote] into CoaST ii Continued access if they meet the previously described criteria. Sites are advised to obtain consent (see attached document) for CoaST ii Continued access prior to any potential use, so that patients can be made fully aware of the device's risks and benefits under non-emergent conditions. it is not our intention that these devices be used for [Quote]off-label[Quote] indications. Covered CP stents for compassionate use outside of the aorta should be provided by the manufacturer, nuMeD, inc. emergency use of these devices is permitted as long as site investigator adheres to as many Patient Protection measures as possible prior to implantation.
Data collection of Continued acces patients will be for observational purposes, no statistical comparisons are planned.
Native or recurrent aortic coarctation*associated with one or more of the following:
1. Acute or chronic aortic wall injury+
2. Nearly atretic descending aorta to 3 mm or less in diameter.
3. Genetic Syndromes associated with aortic wall weakening. Individuals with genetic syndromes such as Marfan Syndrome, Turner[Single Quote]s Syndrome or familial bicuspid aortic valve and ascending aortic aneurysm.
4.Advanced age. Men and woman aged 60 years or older.
* 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
It has been proposed to include in this trial patients who have been treated with Covered CP stents and followed prospectively at a COAST IDE center. This site has two such patients. These two patients have been transferred from STU 102010-084
* Compassionate use of covered stent for Aortic Coarctation associated with large aneurysm.[Double Quote]