CompletedNot Applicable

PerQseal® Impella Early Feasibility Study

United States19 participantsStarted 2021-06-29

Plain-language summary

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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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,
. Duration of Impella use \> 8 hours and ≤ 4 days if used for cardiogenic shock
. Duration of Impella use ≤ 6 hours if used for PPCI.
. Impella access sheath between 13 and 14 F,
. Potential subject or authorized representative willing and able to provide appropriate study-specific informed consent,
. Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety: Major Access Site Complications

Timeframe: through 30 days

Efficacy: Time to Hemostasis

Timeframe: 20 minutes

Trial details

NCT IDNCT04818541

SponsorVivasure Medical Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-01

View on ClinicalTrials.gov More Percutaneous Large Hole Vascular Closure trials

Plain-language summary

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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,
. Duration of Impella use \> 8 hours and ≤ 4 days if used for cardiogenic shock
. Duration of Impella use ≤ 6 hours if used for PPCI.
. Impella access sheath between 13 and 14 F,
. Potential subject or authorized representative willing and able to provide appropriate study-specific informed consent,
. Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.

PerQseal® Impella Early Feasibility Study

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

PerQseal® Impella Early Feasibility Study

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria