B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Eric Roselli, M. D.590 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

590

Conditions

Thoracic Aortic Aneurysm Aortic Dissection Congenital Aortic Anomaly

Interventions

B-SAFERDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. At least 18 years of age 2. Subject is willing and able to give written informed consent to participate in the study or the subject's legally authorized representative has given written informed consent for the subject to participate in the study. 3. Expected life expectancy of greater than two years after repair 4. Subject has aortic pathology and requires repair or replacement of multiple damaged or diseased segments of the thoracic aorta (at least one of the following condition): Thoracic aortic aneurysm considered at increased risk for rupture or complications, Acute aortic dissection requiring urgent repair, Congenital aortic disease requiring repair Exclusion Criteria: 1. Subject is unfit for open surgical repair involving circulatory arrest 2. Subject is comatose or suffering from irreversible severe brain malperfusion 3. Subject has known sensitivity to components of the devices 4. Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure 5. Subject is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study 6. Subject has an uncorrectable bleeding anomaly 7. Subject has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post- procedure 8. Subject is pregnant

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

All-cause mortality

Individual rate of occurrence of the death from all-cause

Time frame: Up to 30 days

Stroke, excluding TIA

Individual rate of occurrence of stroke

Time frame: Up to 30 days

Paralysis, excluding paraparesis

Individual rate of occurrence of paralysis

Time frame: 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

Time frame: 24 hours

Patency of all graft/endograft components

Patent graft/endografts confirmed by CT imaging assessment

Time frame: 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

Time frame: At hospital discharge or 1 month

Secondary Outcomes

Aortic related death

Individual rate of the aortic related death

Time frame: Up to 36 months after the index procedure

Pseudoaneurysm at the treatment sites

Individual rate of the pseudoaneurysm at the treatment sites

Central Contacts

Eric Roselli, M. D.

CONTACT

216-444-0995 roselle@ccf.rg

Yuki Kuramochi, BSN, RN

CONTACT

2164454063 kuramoy@ccf.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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

Time frame: Up to 36 months after the index procedure

Late Type I endoleak

Individual rate of the Type I endoleak confirmed by CT imaging assessment

Time frame: Up to 36 months after the index procedure

Late Type III endoleak

Individual rate of the Type III endoleak confirmed by CT imaging assessment

Time frame: Up to 36 months after the index procedure

Non-cardiac/non-aortic re-operations

Individual rate of non-cardiac/non-aortic re-operations

Time frame: Up to 36 months after the index procedure

Vocal Cord paralysis

Individual rate of vocal cord paralysis

Time frame: Up to 36 months after the index procedure

Myocardial infarction

Individual rate of myocardial infarction

Time frame: Up to 36 months after the index procedure

Respiratory failure

Individual rate of respiratory failure

Time frame: Up to 36 months after the index procedure

Renal failure requiring dialysis

Individual rate of renal failure requiring dialysis

Time frame: Up to 36 months after the index procedure

Thromboembolic events

Individual rate of thromboembolic events

Time frame: 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)

Time frame: 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

Time frame: Up to 36 months after the index procedure

Aortic rupture

Individual rate of aortic rupture

Time frame: Up to 36 months after the index procedure

Device integrity failures

Individual rate of device integrity failures confirmed by CT imaging assessment

Time frame: Up to 36 months after the index procedure

Device crimping/kinking

Individual rate of device crimping/kinking confirmed by CT imaging assessment

Time frame: 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

Time frame: 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

Time frame: Up to 36 months after the index procedure

Surgical graft/stentgraft infection

Individual rate of surgical graft/stentgraft infection

Time frame: Up to 36 months after the index procedure

Incidence of all endoleak types

Individual rate of all endoleak types confirmed by CT imaging assessment

Time frame: 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

Time frame: Up to 36 months after the index procedure

Non-serious and serious adverse events

Individual rate of non-serious adverse events

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to 36 months after the index procedure

Incidence of secondary procedures related to the extension

Individual rate secondary procedures related to the extension

Time frame: Up to 36 months after the index procedure