Rapidlink device for repairing aortic arch branch vessels during open thoracic aorta surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolls adults already scheduled for elective open thoracic aortic repair who will have one or more supra‑aortic vessels repaired or replaced. Surgeons will implant the Rapidlink stented graft into the left subclavian, left common carotid, and/or innominate artery to secure the branch with minimal sutures and manipulation. The first 32 patients will receive the device in the left subclavian artery only, after which enrollment expands to include other supra‑aortic vessels and an additional cohort of subjects. The study collects perioperative and follow‑up safety and effectiveness data to determine procedural efficiency, vessel patency, and the need for additional bypass or transposition procedures.

Why it matters

Who can join: the full rules

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)

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• Barnes-Jewish Hospital
  St Louis, Missouri, United States Recruiting
• Hospital of the University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Acension Seton Medical Center
  Austin, Texas, United States Recruiting
• Baylor Scott & White The Heart Hospital - Plano
  Plano, Texas, United States Recruiting
• Froedhert Hospital
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Study coordinator: Sarah Macluskie
• Email: s.macluskie@terumoaortic.com
• Phone: +441413430333

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.