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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
NCT07078383 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE Rapidlink
Study Locations (20)
Other
- University Hospital Vienna — Vienna
- University Medical Center Freiburg — Freiburg im Breisgau
- University Medical Center Hamburg-Eppendorf — Hamburg
- Robert Bosch Hospital — Stuttgart
Florida
- UF Health Shands Hospital — Gainesville
- Baptist Hospital of Miami — Miami
- Tampa General Hospital — Tampa
California
- Keck Medicine of USC — Los Angeles
- Cedars-Sinai Medical Center — Los Angeles
Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia
- UPMC Presbyterian — Pittsburgh
Texas
- Acension Seton Medical Center — Austin
- Baylor Scott & White The Heart Hospital - Plano — Plano
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
District of Columbia
- Medstar Washington Hospital Center — Washington D.C.
Illinois
- Northwestern Memorial Hospital — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-12-19 |
| Est. Completion | 2028-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07078383
The ClinicalTrials.gov registry entry for NCT07078383 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vascutek, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Aortic Aneurysm appearing as the primary indexed condition, and to 1 intervention — of which Rapidlink is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07078383 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07078383 about?
NCT07078383 is a clinical study titled "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". 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 ha...
What is the current status of trial NCT07078383?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2025-12-19. Estimated completion is 2028-11.
What conditions does trial NCT07078383 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Aortic Diseases, Aneurysmal Disease, Aortic Aneurysm and Dissection, Aneurysm of Aorta, Thoracic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07078383?
The interventions under investigation include: Rapidlink (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07078383?
This trial is sponsored by Vascutek, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07078383 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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