Last reviewed · How we verify
NCT04799769
Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study
NA trial testing Percutaneous arterial closure device in Percutaneous Arteriotomy Closure in 90 participants. Status unknown.
10 January 2023
Quick facts
| Lead sponsor | Vivasure Medical Limited |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 10 March 2021 |
| Primary completion | 10 January 2023 |
| Estimated completion | 10 March 2023 |
| Sites | 5 locations across Netherlands, Germany |
Drugs / interventions tested
- Percutaneous arterial closure device
Conditions studied
- Percutaneous Arteriotomy Closure — all drugs for Percutaneous Arteriotomy Closure →
Sponsor
Vivasure Medical Limited
Who can join
18 and older, any sex, with Percutaneous Arteriotomy Closure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites. The PerQseal® + shall be indicated for the percutaneous closure of femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created with 14 - 22F sheaths (arteriotomy up to 26 F).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Frontier V Study: Evaluating the Safety and Clinical Performance of a Large-Bore Vascular Closure Device After Femoral Arterial Access.
Frerker C, Schwindt A, Schmidt A, Schmidt T, et al · · 2025 · cited 1× · PMID 40343429 · DOI 10.1002/ccd.31574
Verify or expand the search:
- PubMed search for NCT04799769
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Vivasure Medical Limited trials
Trials by the same sponsor.
- NCT05163548 — PerQseal®+ Early Feasibility Study · NA · completed
- NCT04818541 — PerQseal® Impella Early Feasibility Study · NA · completed
- NCT03423602 — Safety and Performance Study of Large Hole Vascular Closure Device FIV · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04799769 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vivasure Medical Limited
- Last refreshed: 12 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04799769.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing