Recruiting

Rapidlink Device

Sponsor:

Vascutek Ltd.

Code:

NCT07078383

Conditions

Aortic Aneurysm

Aortic Aneurysm and Dissection

Aortic Diseases

Aneurysm of Aorta, Thoracic

Aneurysmal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rapidlink

Study Details

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 Aneurysm and Dissection

Aortic Diseases

Aneurysm of Aorta, Thoracic

Aneurysmal Disease

Study ID

NCT07078383

Start date

Dec 19, 2025

Status verified date

Jul, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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 a known chronic aortic dissection involving the intended landing zone of the target supra-aortic vessel(s)

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rapidlink Device

Interventions

Rapidlink

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sarah Macluskie

+441413430333s.macluskie@terumoaortic.com

Michelle Durnan

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

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Study Coordinator

+1 (443) 927-3983zyriah.robinson@jhmi.edu

Principal Investigator:

Mehrdad Ghoreishi

Barnes-Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Coordinator

+1 (314) 747-1926aschuck@wustl.edu

Principal Investigator:

Puja Kachroo

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Research Supervisor

+1 (215) 349-8752elizabeth.durham@pennmedicine.upenn.edu

Principal Investigator:

Nimesh Desai

Acension Seton Medical Center

Recruiting

Austin, Texas, United States, 78705

Contacts

Study Coordinator

+1 (512) 324 3434andrea.stapper@ascension.org

Principal Investigator:

Joshua Grimm

Baylor Scott & White The Heart Hospital - Plano

Recruiting

Plano, Texas, United States, 75093

Contacts

Cardiovascular Research Supervisor

+1 469-814-3278osniel.gonzalezramos@bswhealth.org

Principal Investigator:

William Brinkman

Froedhert Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Clinical Research Manager

+1 (414) 955-6994jzelten@mcw.edu

Principal Investigator:

Jorge Mascaro

More Information

Sponsor

Vascutek Ltd.

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vascutek Ltd. on 2026-07-27.