Rapidlink Device for Aortic Disease

(RAPID Trial)

Not yet recruiting at 22 trial locations

Overseen By Michelle Durnan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vascutek Ltd.

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Uncontrolled hypercoagulation, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Rapidlink device during surgery for repairing or replacing certain arteries connected to the aorta, the large blood vessel in the chest. It focuses on patients already planning thoracic aorta surgery (the part of the aorta in the chest) and involves using the Rapidlink device for specific artery repairs or replacements. Initially, it includes patients needing repair or replacement of the left subclavian artery and later expands to other arteries. Suitable candidates are those needing thoracic aorta surgery and expecting to use the Rapidlink device for certain artery repairs. As an unphased trial, this study offers patients the chance to contribute to advancements in surgical devices.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be able to receive blood-thinning medications during and after the procedure.

What prior data suggests that the Rapidlink device is safe for aortic surgery?

The Rapidlink device is a new tool tested for surgeries on the aorta, particularly in the upper chest area. Although clear data on its safety from other studies is not yet available, its inclusion in a clinical trial indicates sufficient promise for further study.

In trials like this, safety remains the top priority. Researchers gather information from patients before, during, and after surgery to ensure the device is safe and effective. This process includes monitoring for any side effects or problems. As the trial is in the early stages, the device undergoes close observation to assess patient response.

Sometimes, new devices like this one are already approved for other uses, which can offer some reassurance about their safety. However, the main goal is to collect specific data during the trial to ensure safety for its intended purpose. Prospective participants should discuss any concerns with the study team or their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Rapidlink Device is unique because it offers a potentially less invasive approach to treating aortic disease compared to traditional open-heart surgery. While most current treatments require major surgery with long recovery times, the Rapidlink Device aims to simplify the process by using a minimally invasive method that could significantly reduce recovery time and complications. Researchers are excited about this device because it could improve patient outcomes by making the treatment safer and more accessible to those who might not be candidates for conventional surgery.

What evidence suggests that the Rapidlink device is effective for aortic disease?

Research has shown that the Rapidlink device makes surgeries on blood vessels near the aorta quicker and easier. In this trial, participants will receive the Rapidlink device during open surgery to connect these vessels to a graft, a piece of material used in the operation. The device simplifies the procedure and shortens surgery time, which is crucial for patient recovery. Early results suggest that this device could repair or replace the vessels with more accuracy and less strain on the body. While specific effectiveness data is still being gathered, the goal is to improve outcomes in aortic surgeries. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for patients who need open surgery to fix their aorta due to conditions like aneurysms or dissections. Initially, only those needing left subclavian artery repair with Rapidlink will be included. Later, it expands to other supra-aortic vessels and emergency cases.

Inclusion Criteria

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

I am 18 years old or older.

Exclusion Criteria

Patient has a condition which may compromise or prevent the necessary imaging requirements

Patient has known sensitivity to polyester, nitinol, tantalum, or materials of bovine origin

Patient does not have a sealing zone free from tortuosity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure

Data collection and preparation for the surgical procedure

1 week

1 visit (in-person)

Surgical Procedure

Participants undergo open surgical repair of the aorta with the Rapidlink device

1 day

1 visit (in-person)

Recovery and Initial Follow-up

Participants are monitored post-surgery at discharge and 30 days for safety and effectiveness

4 weeks

2 visits (in-person)

Long-term Follow-up

Participants are monitored for safety and effectiveness at 6 months, 12 months, and 24 months post-procedure

24 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Rapidlink

Trial Overview The study tests the safety and effectiveness of the Rapidlink device during aortic surgery. It starts with repairs involving the left subclavian artery, then includes other arteries after 32 people join. Emergency surgeries are also considered after this point.

How Is the Trial Designed?

Group I: Rapidlink Device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vascutek Ltd.

Lead Sponsor

Trials

18

Recruited

5,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07078383

NCT07078383 | A Study to Evaluate the Safety and ... This study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07078383?term=AREA%5BConditionSearch%5D(%22Aortic%20Aneurysm%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=1

A Study to Evaluate the Safety and Effectiveness ... 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 ...

3. annalscts.com annalscts.com/article/view/17203/html

a new technology to simplify the supra-aortic vessel ... The intended use of the device is to achieve faster and easier anastomosis of the supra-aortic arch vessels, particularly the LSA, during open ...

4. withpower.com withpower.com/trial/phase-aortic-aneurysm-8-2025-c4d22

Rapidlink Device for Aortic Disease (RAPID Trial) 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12519289/

RapidlinkTM: a new technology to simplify the supra-aortic ... The RapidlinkTM device is a conjunctive device, designed to simplify anastomosis of the main arch vessels to the graft being used to replace the aortic arch ...

6. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-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/555744140

Clinical Trial: A Study to Evaluate the Safety and ... This study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device ...