Thoraflex Hybrid and Relay Extension Post-Approval Study

Aortic Aneurysm Clinical Trial

— EXTEND  

Official title:

Thoraflex Hybrid and Relay Extension Post-Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639400
• Other study ID #: EXTEND-001
• Status: Recruiting
• Start date: March 17, 2023
• Est. completion date: December 2036

Study information

• Verified date: June 2023
• Source: Vascutek Ltd.
• Contact: Donna McDougall
• Phone: +441418125555
• Email: d.mcdougall[@]terumoaortic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2036
• Est. primary completion date: December 2035
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patient is aged 18 years or older on date of consent. Patient is willing and able to comply with all study procedures and visits. Patient or their next of kin (NOK)/legally designated representative (LDR) has given written informed consent to participate in the study. Patient will undergo treatment with a Thoraflex Hybrid device. If a patient requires an extension procedure due to the extent of aortic disease, a RelayPro NBS Stent-graft should be placed inside the distal end of the previously placed Thoraflex Hybrid device via a retrograde approach. This may be part of the same or a two-stage procedure.

Exclusion Criteria:

• Patient has any 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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Dissection
• Thoracic Aortic Aneurysm
• Thoracic Aortic Dissection
• Thoracic Diseases

Intervention

Device:
• Thoraflex Hybrid
Thoraflex Hybrid is designed for the open surgical repair of aneurysms and/or dissections in the aortic arch and descending aorta with or without involvement of the ascending aorta. There are two types of Thoraflex Hybrid implants, namely the Plexus 4 and the Ante-Flo versions. Each patient receives one Thoraflex Hybrid device (either the Plexus 4 or Ante-Flo).
• RelayPro NBS
The RelayPro NBS Thoracic Stent-Graft System is an endovascular device intended for treatment of thoracic aortic pathologies such as aneurysms, pseudoaneurysms, dissections, penetrating ulcers and intramural hematoma.

Locations

Country	Name	City	State
Germany	University of Freiburg	Freiburg
United States	University of Colorado	Aurora	Colorado
United States	University of Alabama in Birmingham Medical Center	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Duke University Medical Centre	Durham	North Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Baylor College of Medicine - St. Luke's	Houston	Texas
United States	Cedars-Sinai Medical Centre	Los Angeles	California
United States	Keck Medical Centre of USC	Los Angeles	California
United States	Weill Cornell medicine	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	Washington University/Barnes Jewish Hospital	Saint Louis	Missouri
United States	Medstar Washington Hospital Centre	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Vascutek Ltd.	Bolton Medical

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint is a composite of the following:	Permanent disabling stroke (mRS >2 and an increase in at least one mRS category from the individual's pre-stroke baseline, occurring within 30 days of either index procedure or extension and present at 1-year follow-up)* Note: If a subject dies prior to 1-year follow-up, their last recorded mRS will be considered their final score; Grade 3 spinal cord ischemia (SVS reporting standards) occurring within 30 days of either index procedure or extension; All-cause mortality (within 1 year of either procedure); (*Per VARC-3, disability assessment using the mRS should be performed between 30 and 90 days after a neurological event with 90 days being optimal. An increased mRS score by itself and in the absence of a neurological event does not constitute stroke.)	The primary safety endpoint will be measured at one-year after the index procedure and again at least 8 months after the (first) extension procedure.
Primary	Primary Safety Endpoint is a composite of the following:	Permanent disabling stroke (mRS >2 and an increase in at least one mRS category from the individual's pre-stroke baseline, occurring within 30 days of either index procedure or extension and present at 1-year follow-up)*; Grade 3 spinal cord ischemia (SVS reporting standards) occurring within 30 days of either index procedure or extension; All-cause mortality (within 1 year of either procedure) (*Per VARC-3, disability assessment using the mRS should be performed between 30 and 90 days after a neurological event with 90 days being optimal. An increased mRS score by itself and in the absence of a neurological event does not constitute stroke.)	The primary safety endpoint will be measured again at least 8 months after the (first) extension procedure.
Primary	Primary Effectiveness Endpoint: Treatment Success	Defined as device technical success (of either procedure) with absence of the following at 1-year: Lesion-related mortality (defined as all deaths occurring within 30 days of, or, prior to discharge, from either the index procedure or the extension procedure or any revision procedures to treat the original lesion(s) and any other deaths adjudicated by Clinical Events Committee as related or probably related to the lesion(s)); Aortic rupture in the treated segment; Lesion expansion (=5mm increase from measurement at discharge/within 30 days); Secondary intervention to address the following: Stent graft-induced aortic wall injury (SAWI); Fistula; Type I or III endoleak (see definitions); Migration; Loss of Patency; Thromboembolic events; Failure of integrity	The primary effectiveness endpoint will be measured at one-year after the index procedure.
Primary	Primary Effectiveness Endpoint: Treatment Success	Defined as device technical success (of either procedure) with absence of the following at 1-year: Lesion-related mortality (defined as all deaths occurring within 30 days of, or, prior to discharge, from either the index procedure or the extension procedure or any revision procedures to treat the original lesion(s) and any other deaths adjudicated by Clinical Events Committee as related or probably related to the lesion(s)); Aortic rupture in the treated segment; Lesion expansion (=5mm increase from measurement at discharge/within 30 days); Secondary intervention to address the following: Stent graft-induced aortic wall injury (SAWI); Fistula; Type I or III endoleak; Migration; Loss of Patency; Thromboembolic events; Failure of integrity	The primary effectiveness endpoint will be measured again at least 8 months after the (first) extension procedure.
Secondary	Secondary Safety Endpoints, Absence of the following	All-cause mortality, and; Lesion-related mortality (defined as all deaths occurring within 30 days of, or, prior to discharge, from either the index procedure or the extension procedure or any revision procedures to treat the original lesion(s) and any other deaths adjudicated by Clinical Events Committee as related or probably related to the lesion(s)); All/any paraplegia/paraparesis defined as SCI (SVS grades 1 to 3); Any stroke (excluding TIA); Incidence of Myocardial Infarction; Incidence of Respiratory Failure; Incidence of Renal Failure; Incidence of Bowel Ischemia	The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.
Secondary	Secondary effectiveness endpoints will be reported	Any aortic rupture (treated and untreated segments); Aortic remodeling in the treated segment(s); New dissections; Proximal and distal extension of dissections; Any false lumen perfusion (specifying location and if intentional or not); Fistula formation; All endoleaks; Device migration (measure both >5mm from position at discharge/within 30 days, and >10 mm from position at discharge/within 30 days, and requiring secondary intervention); Device integrity issues (e.g., stent fracture); All thromboembolic events; Pseudoaneurysms (device-related); Secondary Interventions; Graft patency (loss of patency will be defined as an opening of <50% due to, for example, occlusion, stenosis, kinking)	The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.