Thoraflex™ Hybrid IDE Study

NCT02724072 | Completed DMC

• 1 other identifier: HYBRID-002
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 12

Brief Summary

The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of ascending aorta. The study will also assess safety and early clinical outcomes in patients who receive an extension procedure within 1 year of Thoraflex™ Hybrid Device implantation. Lastly the study will assess the safety and clinical outcomes of patients who receive a Thoraflex™ Hybrid Device for treatment of a ruptured aorta. Patients will be followed for 3 years. The Primary Endpoint will be freedom from defined Major Adverse Events (MAE) occurring ≤ 1 year post-procedure.

Conditions

Aortic Aneurysm; Aortic Dissection; Aortic Rupture

Keywords

Thoracic Surgery; Aortic Arch; Frozen Elephant Trunk; Performance Goal

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who are free from composite Major Adverse Events (Permanent stroke, Permanent paraplegia/paraparesis, Unanticipated aortic-related re-operation, All-cause mortality) at 1 year post-procedure

  Freedom from the following composite Major Adverse Events (MAE) occurring ≤ 1 year post-procedure: * Permanent stroke * Permanent paraplegia/paraparesis * Unanticipated aortic-related re-operation (excluding re-operation for bleeding) * All-cause mortality All relevant events will be adjudicated by CEC. Data will be analysed and presented in a binary format (i.e. Freedom from the listed AE's - Yes/No).

  ≤ 1 year post-procedure

Secondary Outcomes (4)

• Device Technical Success

  At exit from OR (i.e. completion of surgical procedure)

• Procedural Success

  At discharge/30 days

• Treatment Success

  At discharge/30 days and all post-procedural intervals

• Individual Patient Success

  At 1 year

Study Arms (1)

Thoraflex™ Hybrid Device.

EXPERIMENTAL

Plexus™ 4 and Ante-Flo™ configurations will be included in this study.

Device: Thoraflex™ Hybrid Device

Interventions

Thoraflex™ Hybrid Device DEVICE

Single-use medical device sterilized by ethylene oxide which is pre-loaded into a delivery system. The device comprises a gelatin sealed vascular graft combined with a stented graft.

Thoraflex™ Hybrid Device.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Main Study Group (All patients except Aortic Rupture Patients)
• Patient is aged 18 years or over on date of consent
• Patient is willing and able to comply with all study procedures and study visits
• Patient or their legally authorized representative has given written informed consent to participate in study
• A - Patient has acute dissection of the aorta or B - Patient has chronic dissection of the aorta or C - Patient has an aortic aneurysm (including connective tissue disorders)
• A. - Patients with acute dissection of the aorta:
• Patient has acute aortic dissection and requires repair or replacement of damaged or diseased vessels of the aortic arch (with or without involvement of the ascending aorta), and the descending aorta requires replacement, or, in the opinion of the investigator, the patient would derive clinical benefit from prophylactic treatment of the descending aorta.
• B. - Patients with chronic dissection of the aorta:
• Patient requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta due to chronic dissection.
• And patient satisfies one or more of the following criteria:
• Patient has aortic sinus, or ascending aorta, or aortic arch, or descending aorta diameter ≥5.5cm (including if asymptomatic) or
• Patient has aorta diameter \<5.5cm and growth rate ≥0.5cm/year (including if asymptomatic) or
• Patient has ascending aorta diameter ≥4.5cm and requires valve repair or replacement
• C. - Patients with an aortic aneurysm (including connective tissue disorders):
• Patient requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta

You may not qualify if:

• Main Study Group (All Patients Except Patients with Ruptured Aorta)
• Patient is unfit for open surgical repair involving circulatory arrest
• Patient has known sensitivity to polyester, nitinol or materials of bovine origin
• Patient has a ruptured aorta
• Patient has active endocarditis or an active infective disorder of the aorta
• Patient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
• Patient 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
• Patient is female and is pregnant, or planning to become pregnant during the course of the study. Females of childbearing potential must use acceptable methods of contraception.
• Patient has an uncorrectable bleeding anomaly
• Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.5mg/dL)
• Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated
• Patient has a co-morbidity causing expected survival to be less than 1 year
• Patient 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
• Patient has chronic dissection which, in the opinion of the investigator, can be treated electively
• Patient has aneurysmal disease which, in the opinion of the investigator, can be treated electively

Sponsors & Collaborators

• Bolton Medical: lead
• Vascutek Ltd.: collaborator

Study Sites (12)

Stanford University Medical Center

Palo Alto, California, 94305-5407, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5853, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

NY Presbyterian Weill Cornell

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 10104, United States

Location

University of Pittsburgh Medical Center (UPMC) Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor St. Luke's

Houston, Texas, 77030, United States

Location

University of Texas Houston- Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Links

• Thoraflex™ Hybrid device

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Dissection; Aortic Rupture

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aneurysm, Ruptured; Rupture; Wounds and Injuries

Study Officials

• Joseph S Coselli

  Baylor St. Luke's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 31, 2016
• Study Start: August 22, 2016
• Primary Completion: June 24, 2019
• Study Completion: July 30, 2021
• Last Updated: May 16, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)