NCT07205068 Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
| NCT ID | NCT07205068 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Tennessee Graduate School of Medicine |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-04 |
| Primary Completion | 2026-11-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-10-04 with a primary completion date of 2026-11-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)
Eligibility Criteria
Inclusion Criteria: 1. \>18 years of age 2. Patient with a diagnosis of severe aortic stenosis undergoing TAVR 3. Participants must be able to read and understand study procedures 4. Willing to participate and sign an ICF 5. Patients with \> 90-degree arc of calcium at the large bore access site per CT documentation Exclusion Criteria: 1. Unable to understand study procedures 2. Unwilling to give consent 3. Patients with cognitive impairments that can affect their ability to give consent 4. Unfavorable calcium distribution of femoral artery
Frequently Asked Questions
Who can join the NCT07205068 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07205068 currently recruiting?
Yes, NCT07205068 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Tennessee Graduate School of Medicine to inquire about joining.
Where is the NCT07205068 trial being conducted?
This trial is being conducted at Knoxville, United States.
Who is sponsoring the NCT07205068 clinical trial?
NCT07205068 is sponsored by University of Tennessee Graduate School of Medicine. The trial plans to enroll 100 participants.