Shockwave Assisted Large Bore Access
Public ClinicalTrials.gov record NCT04600934. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Shockwave Assisted Large Bore Access (TAVR, TEVAR, EVAR, FEVAR)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Annually, 150-200 TAVR with unilateral large bore access and 200 combined TEVAR/EVAR/FEVAR with bilateral large bore access are performed at our institution. Nearly 50 percent of patients fall outside IFU for access vessel size. Adjuncts described include iliac conduit, crack and pave, balloon expandable sheaths, direct aortic puncture, transcaval delivery, alternative access point (i.e axillary, carotid). Each of these adjuncts comes with additional complication potential and by nature of being used less frequently than the standard femoral access makes the procedure more challenging. The intervention the use of the Shockwave Medical, Inc. Peripheral Lithoplasty® System to achieve large bore access in patients whose vessels fall outside of the IFU suggested dimensions.
Study identification
- NCT ID
- NCT04600934
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2, 2022
- Primary completion
- Sep 27, 2023
- Completion
- Sep 27, 2023
- Last update posted
- Sep 2, 2024
2022 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04600934, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2024 · Synced Sep 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04600934 live on ClinicalTrials.gov.