Is NCT07078383 recruiting in Gainesville, FL?

Yes, NCT07078383 is currently recruiting participants at its Gainesville, FL location. This aortic aneurysm clinical trial is actively enrolling qualified participants.

How do I join the aortic aneurysm clinical trial in Gainesville?

To join this clinical trial in Gainesville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Gainesville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Aortic Aneurysm Clinical Trial in Gainesville, FL

About This Aortic Aneurysm Study in Gainesville

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.

Sponsor: Vascutek Ltd.

Who Can Participate

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Gainesville?

Yes, this clinical trial (NCT07078383) has an active research site in Gainesville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Aortic Aneurysm Treatment Options in Gainesville, FL

If you're searching for aortic aneurysm treatment options in Gainesville, FL, this clinical trial (NCT07078383) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Gainesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic aneurysm specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all aortic aneurysm clinical trials near you to find additional studies recruiting in your area.

Aortic Aneurysm Clinical Trial in Gainesville, FL

Expert Care in Gainesville

IRB Approved

No-Cost Care

Apply for This Gainesville Location

Why Participate?

Simple Process