Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01278303 | Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta | PHASE2 | COMPLETED | 82 | — | — | Jul 1, 2010 | Dec 1, 2014 | Apr 11, 2023 | 19 | United States |
Severity of Illness Scale (SIS) improvement increase of at least 1 grade from baseline to 12 month follow-up SIS is divided into 3 conditions \& 5 grades of severity: 1 = worst (reserved for AWI) , 5 = best) C1 Upper Extremity Systolic Blood Pressure (SBP) 2- \> 159 mmHg or any hpn on \>2 medications 3- 140-159 mmHg or elevated SBP on \>2 medications 4- 130-139 mmHg or normal SBP on \>2 medications 5- \<130 mmHg on 0-2 meds C2 Upper Extremity to Lower Extremity SBP difference 2- \>59 mmHg 3- 30-59 mmHg 4- 15-29 mmHg 5- \<15 mmHg C3 Aortic Wall Injury severity levels: 1. Uncontained rupture or large aneurysm 2. Contained rupture or stable large aneurysm 3. Small contained rupture or moderate aneurysm 4. Acute, but stable AWI or small aneurysm 5. No injury or minor aortic wall irregularity not in need of treatment. * Grades for conditions represent comparable degrees of illness (0 worst, 5 best) -Grade 0 denotes death related to coarctation or study therapy
| Arm | Type | Description |
|---|---|---|
| Treatment of Aortic Wall Injury | OTHER | Repair of aortic wall injury with covered CP Stents |
| Name | Type | Description |
|---|---|---|
| Treatment of Aortic Wall Injury | DEVICE | A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients. |
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...