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Procedure

Cardiogenic shock for Percutaneous Vascular Closure

N/A
Waitlist Available
Research Sponsored by Vivasure Medical Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 19 years
Use of an Impella CP or 2.5 Impella device via the common femoral artery for protected percutaneous coronary intervention (PPCI) or cardiogenic shock
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 30 days
Awards & highlights

Study Summary

This trial will assess the feasibility of using the PerQseal device to close femoral arterial access sites in patients who have undergone either cardiogenic shock or PPCI procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy: Time to Hemostasis
Safety: Major Access Site Complications
Secondary outcome measures
Efficacy: Overall Procedural Time
Efficacy: PerQseal® Device Technical Success Rate
Efficacy: PerQseal® Treatment Success Rate
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Protected Percutaneous Coronary InterventionExperimental Treatment1 Intervention
Subjects with a femoral arteriotomy created with 13 to 14 F sheaths (arteriotomy up to approximately 18 F) and in whom an Impella device was used for PPCI. Duration of Impella use ≤ 6 hours if used for PPCI.
Group II: Cardiogenic shockExperimental Treatment1 Intervention
Subjects with a femoral arteriotomy created with 13 to 14 F sheaths (arteriotomy up to approximately 18 F) and in whom an Impella device was used for cardiogenic shock. Duration of Impella use > 8 hours and ≤ 4 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiogenic shock
2021
N/A
~20
PPCI
2021
N/A
~20

Find a Location

Who is running the clinical trial?

Vivasure Medical LimitedLead Sponsor
10 Previous Clinical Trials
649 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research program accept new participants?

"Affirmative. Clinicaltrials.gov indicates that this study, which was first published on June 29th 2021, is presently recruiting participants. Approximately 20 individuals are being sought from 4 distinct clinical sites."

Answered by AI

What do researchers expect to discover as a result of this investigation?

"The main objective, set to be assessed over a 20 minute duration according to Vivasure Medical Limited (the trial's sponsor), is Safety: Major Access Site Complications. Additionally, the study will examine secondary objectives such as Safety: Incidence of Minor Access Site Complications measured using FDA-provided definitions, Efficacy: PerQseal® Treatment Success Rate determined by calculating the portion of subjects meeting technical success without major complications against those where deployment was attempted and finally The PerQseal® Device Technical Success Rate which pertains to devices achieving hemostasis with or without adjunctive manual compression at target access sites relative to all"

Answered by AI

What is the geographic scope of this experiment?

"Currently, 4 sites are enrolling patients in this study - located at Ridgewood, Buffalo and Stony Brook. It is best to choose the closest centre so as to limit travelling commitments if you decide to join the trial."

Answered by AI

How many individuals are being recruited to participate in this research?

"Affirmative. Details available on clinicaltrials.gov verify that this research is currently seeking individuals to participate in the trial, which was first posted June 29th 2021 and last updated April 11th 2022. The study requires 20 patients from 4 distinct sites for enrollment."

Answered by AI
~5 spots leftby Mar 2025