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

NCT07078383 | Recruiting DMC FDA Device

• 1 other identifier: RAPID-001
• Study Type: interventional
• Target: 150
• Locations: 6 countries
• Sites: 23

Brief Summary

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.

Conditions

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

Keywords

Vascular Prosthesis; Replacement or bypass of disease vessels; aneurysmal disease; Aortic branch vessels; Open aortic arch repair; aneurysm; dissection; Supra-aortic Vessels; Frozen Elephant Trunk; Left Subclavian Artery

Outcome Measures

Primary Outcomes (1)

• The absence of a major adverse event (MAE) at 6-month post procedure.

  The primary endpoint is the absence of a major adverse event (MAE) at 6-month post procedure. MAE are defined as follows are will be assessed as composite and individually: Permanent disabling stroke Permanent paraplegia/paraparesis Device-related (Rapidlink) reinterventions All-cause mortality * Device-related mortality (arch graft and/or branch graft) * Procedure-related mortality * Not device or procedure related

  6 months post procedure

Secondary Outcomes (15)

• Technical Success of the Rapidlink portion of the procedure

  30 days post-procedure

• Clinical Success (Total Arch Repair)

  At discharge/30 days, 6-Months, 12 Months and 24 Months post-procedure

• Rate of Aortic or supra-aortic vessel rupture

  At discharge/30 days, 6-months, 12 months and 24 months post-procedure

• Rate of Stroke of any type, including transient ischemic attacks

  At discharge/30 days, 6-months, 12 months and 24 months post-procedure

• Rate of Pseudoaneurysm in the treated segment

  At discharge/30 days, 6-months, 12 months and 24 months post-procedure

Study Arms (1)

Rapidlink Device

EXPERIMENTAL

Device: Rapidlink

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.

Rapidlink Device

Eligibility Criteria

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

You may qualify if:

• Patient is aged 18 years or over on date of consent
• Written informed consent (from patient or a legally authorized representative) to participate in study, documenting willingness and ability to comply with all study procedures and study visits (unless an exemption for emergency cases has been IRB / EC approved)
• Patient's need for open surgical repair of the thoracic aorta using a Gelweave graft or a Thoraflex Hybrid device (AnteFlo or Plexus) in line with the applicable IFU
• Anticipated need to use Rapidlink for the repair or replacement of the LSA, LCCA and/or IA during the open surgical repair
• Patient has an 8-15 mm inner diameter (target SAV)
• The diameters of the patient's target supra-aortic vessel(s), fall within the ranges specified in the IFU

You may not qualify if:

• Patient does not have a clear landing zone equal to the implantable stent length which is free from stenosis, calcification or thrombus.
• Patient does not have a sealing zone free from tortuosity.
• Patient has significant angulation (\>79° with an internal radius of less than 6mm) for the full implantable stent length
• Patient cannot receive anticoagulation / antiplatelet therapy during or after the index procedure as per the protocol
• Patient has uncontrolled hypercoagulation
• Patient has a condition which may compromise or prevent the necessary imaging requirements
• Patient has anatomic variants which would compromise circulation to the first branch off the target artery after placement of the Rapidlink device (unless planned and/or otherwise revascularized)
• Patient is unfit for open surgical repair involving circulatory arrest per the study investigator
• Patient has known sensitivity to polyester, nitinol, tantalum, 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 during the course of the study.
• Patient has an uncorrectable bleeding anomaly

Sponsors & Collaborators

• Vascutek Ltd.: lead

Study Sites (23)

Keck Medicine of USC

Los Angeles, California, 90033, United States

NOT YET RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

NOT YET RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

NOT YET RECRUITING

UF Health Shands Hospital

Gainesville, Florida, 32608, United States

NOT YET RECRUITING

Baptist Hospital of Miami

Miami, Florida, 33176, United States

NOT YET RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

NOT YET RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

NOT YET RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15232, United States

NOT YET RECRUITING

Acension Seton Medical Center

Austin, Texas, 78705, United States

NOT YET RECRUITING

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

NOT YET RECRUITING

Froedhert Hospital

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

University Hospital Vienna

Vienna, 1090, Austria

NOT YET RECRUITING

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

NOT YET RECRUITING

Robert Bosch Hospital

Stuttgart, 70376, Germany

NOT YET RECRUITING

Radboud University Medical Center

Nijmegen, Radboud, Netherlands

NOT YET RECRUITING

University Hospital of Bern

Bern, 3010, Switzerland

NOT YET RECRUITING

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Dissection; Aortic Diseases; Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Central Study Contacts

Sarah Macluskie

CONTACT

+441413430333; s.macluskie@terumoaortic.com

Michelle Durnan

CONTACT

+44 141 343 0184; m.durnan@terumoaortic.com

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: June 19, 2025
• First Posted: July 22, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

CH (1); NL (1); GB (1); DE (3); AU (1); US (16)