Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
Not provided
Not provided
Not provided
A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.
The proposed Investigational Device Exemption (IDE) is to assess the safety and preliminary effectiveness of the simplified hybrid frozen elephant trunk repair technique Branched Stented Anastamosis Frozen Elephant Trunk Repair (B-SAFER) which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments. The study will also evaluate the device functionality when using this operative technique for device implantation including multiple components.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-SAFER | Device | Simplified hybrid frozen elephant trunk repair will be performed by utilizing B-SAFER technique which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Individual rate of occurrence of the death from all-cause | Up to 30 days |
| Stroke, excluding TIA | Individual rate of occurrence of stroke | Up to 30 days |
| Paralysis, excluding paraparesis | Individual rate of occurrence of paralysis | Up to 30 days |
| Technical success | Composite of the following criteria: successful delivery of the device through the vasculature, successful deployment of the device at the intended location, and patient survival | 24 hours |
| Patency of all graft/endograft components | Patent graft/endografts confirmed by CT imaging assessment | At hospital discharge or at 1 month |
| Complete sealing of the aortic pathology | Absence of Type Ia and IIIa/b endoleak, complete coverage of PAU cases, and isolation of the primary entry tear in dissection cases confirmed by CT imaging assessment | At hospital discharge or 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic related death | Individual rate of the aortic related death | Up to 36 months after the index procedure |
| Pseudoaneurysm at the treatment sites | Individual rate of the pseudoaneurysm at the treatment sites |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Roselli, M. D. | Contact | 216-444-0995 | roselle@ccf.rg | |
| Yuki Kuramochi, BSN, RN | Contact | 2164454063 | kuramoy@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Eric Roselli, M. D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37802330 | Derived | Roselli EE, Vargo PR, Bakaeen F, Koprivanac M, Burns D, Kuramochi Y, Gillinov M; B-SAFER Investigators. Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study. J Thorac Cardiovasc Surg. 2024 Sep;168(3):746-756. doi: 10.1016/j.jtcvs.2023.09.069. Epub 2023 Oct 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 36 months after the index procedure |
| Unanticipated aortic or branch-related re-operation | Individual rate of the unanticipated aortic or branch-related re-operation | Up to 36 months after the index procedure |
| Late Type I endoleak | Individual rate of the Type I endoleak confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Late Type III endoleak | Individual rate of the Type III endoleak confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Non-cardiac/non-aortic re-operations | Individual rate of non-cardiac/non-aortic re-operations | Up to 36 months after the index procedure |
| Vocal Cord paralysis | Individual rate of vocal cord paralysis | Up to 36 months after the index procedure |
| Myocardial infarction | Individual rate of myocardial infarction | Up to 36 months after the index procedure |
| Respiratory failure | Individual rate of respiratory failure | Up to 36 months after the index procedure |
| Renal failure requiring dialysis | Individual rate of renal failure requiring dialysis | Up to 36 months after the index procedure |
| Thromboembolic events | Individual rate of thromboembolic events | Up to 36 months after the index procedure |
| Failed patencies in graft, or endovascular stent-graft including the branch(es) | Individual rate of failed patencies in gaft or endovascular stent-graft including branch(es) | Up to 36 months after the index procedure |
| Secondary unplanned interventions in the treated vascular segment or related to the original pathology | Individual rate of secondary unplanned interventions in the treated vascular segment or related to the original pathology | Up to 36 months after the index procedure |
| Aortic rupture | Individual rate of aortic rupture | Up to 36 months after the index procedure |
| Device integrity failures | Individual rate of device integrity failures confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Device crimping/kinking | Individual rate of device crimping/kinking confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Device migration | Individual rate of device migration (>10 mm based on the position of the device implantation) compared to baseline confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Thrombosis of the device lumen | Individual rate of thrombosis of the device lumen confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Surgical graft/stentgraft infection | Individual rate of surgical graft/stentgraft infection | Up to 36 months after the index procedure |
| Incidence of all endoleak types | Individual rate of all endoleak types confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Migration of the distal extension | Individual rate of distal extension migration (>10 mm based on the position of the device implantation) confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Non-serious and serious adverse events | Individual rate of non-serious adverse events | Up to 36 months after the index procedure |
| Failure of device-extension integrity resulting in a compromised seal and blood leakage or movement of the device | Individual rate of the extension device integrity issues confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Incidence of Type III endoleak related to the extension device | Individual rate of the Type III endoleak related to the extension device confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Incidence of failed patency of the device-extension overlap | Individual rate of failed patency of the device-extension overlap confirmed by CT imaging assessment | Up to 36 months after the index procedure |
| Incidence of MAE at 30 days post-extension | Individual rate and type of MAE at 30 days post-extension | Up to 36 months after the index procedure |
| Incidence of secondary procedures related to the extension | Individual rate secondary procedures related to the extension | Up to 36 months after the index procedure |
| D001018 |
| Aortic Diseases |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |