Who is sponsoring NCT04818541?

NCT04818541 is sponsored by Vivasure Medical Limited.

What drugs are being tested in NCT04818541?

Interventions in NCT04818541: PPCI, Cardiogenic shock.

What condition does NCT04818541 study?

NCT04818541 studies Percutaneous Large Hole Vascular Closure.

Is NCT04818541 still recruiting?

NCT04818541 is currently completed. Last updated 26 April 2023.

Last reviewed 2023-04-26 · How we verify

NCT04818541

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PerQseal® Impella Early Feasibility Study

Completed NA Last updated 26 April 2023

What this trial tests

NA trial testing PPCI in Percutaneous Large Hole Vascular Closure in 19 participants. Completed in 1 March 2023.

Timeline

29 June 2021

Primary endpoint
1 January 2023

1 March 2023

Quick facts

Lead sponsor	Vivasure Medical Limited
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	29 June 2021
Primary completion	1 January 2023
Estimated completion	1 March 2023
Sites	4 locations across United States

Drugs / interventions tested

PPCI
Cardiogenic shock

Conditions studied

Percutaneous Large Hole Vascular Closure — all drugs for Percutaneous Large Hole Vascular Closure →

Sponsor

Vivasure Medical Limited

Who can join

19 and older, any sex, with Percutaneous Large Hole Vascular Closure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this Clinical Investigation Plan is to assess the initial feasibility results of the PerQseal® device, when used on this very specific Impella population. Safety and effectiveness will be assessed in patients where an Impella device was used for either cardiogenic shock or PPCI. Closure of femoral arterial access sites created with 13 to 14 F sheaths will be studied, assessing the need for alternative therapy other than manual compression or adjunctive endovascular ballooning.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Management of femoral large-bore access and closure during microaxial flow pump-supported interventions.
Vergallo R, Lombardi M, Macchione A, Pescetelli F, et al · · 2026 · PMID 42222124 · DOI 10.3389/fcvm.2026.1816473

Verify or expand the search:

Other trials of PPCI

Trials testing the same drug.

NCT02565147 — Bivalirudin Infusion for Ventricular Infarction Limitation · Phase 3 · terminated

Other Vivasure Medical Limited trials

Trials by the same sponsor.

NCT05163548 — PerQseal®+ Early Feasibility Study · NA · completed
NCT04799769 — Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study · NA · unknown
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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04818541 (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: 26 April 2023

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/NCT04818541.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing