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Tests treatment safety and results for Aortic Aneurysm
Official title 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
ClinicalTrials.gov ID: NCT07078383
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- 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)
You likely can't join 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
See the full eligibility 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...
- 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Austin, Texas, United States
- Plano, Texas, United States
- Milwaukee, Wisconsin, United States
- Vienna, Austria
- Freiburg im Breisgau, Germany
- Hamburg, Germany
- Stuttgart, Germany
- Nijmegen, Radboud, Netherlands
- Bern, Switzerland
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Gainesville, Florida, United States; Miami, Florida, United States; Tampa, Florida, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.