A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta

Conditions

• Aneurysm of Aorta, Thoracic
• Aneurysmal Disease
• Aorta, Thoracic Pathologies
• Aortic Aneurysm
• Aortic Aneurysm and Dissection
• Aortic Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rapidlink — DEVICE
  The Rapidlink implant is comprised of a Gelweave graft section (gelatin-sealed woven polyester) attached to a stented section (which utilizes nitinol ring stents), with a 'cuff'' feature joined to the stented section of the implant. The implant is supplied pre-loaded in a single use delivery system which compacts the stented section within a polytetrafluoroethylene (PTFE) sheath at the front of the system.

Study Details

The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta. This study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels. The first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in a planned surgery. After the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in an emergency setting. Data will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.

Key Dates

Start date

Dec 19, 2025

Status verified

Feb 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2028

Study Design

Enrollment

150 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rapidlink Device

Primary Outcome Measure

The absence of a major adverse event (MAE) at 6-month post procedure. [ Time Frame: 6 months post procedure ]

Central Contacts

• Sarah Macluskie
  +441413430333
  [email protected]
• Michelle Durnan
  +44 141 343 0184
  [email protected]

Locations (16)

Find similar trials in Los Angeles, CA

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