Percutaneous Large Hole Vascular ClosureNCT04818541
PerQseal® Impella Early Feasibility Study
A study testing PPCI and Cardiogenic shock in people with Percutaneous Large Hole Vascular Closure, run by Vivasure Medical Limited at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Percutaneous Large Hole Vascular Closure
- What is being tested?
- PPCI and Cardiogenic shock
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jun 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
- Baseline Exclusion Criteria:
- Evidence of systemic bacterial or cutaneous infection, including groin infection,
- Known bleeding diathesis, definite or potential coagulopathy, platelet count < 100,000/µl or subjects on long term anticoagulants with an INR > 2 within 12 hours prior to index procedure,
- Significant anemia (hemoglobin <9 g/dL or hematocrit < 27%), within 24 hours prior to index procedure,
- Known type II heparin-induced thrombocytopenia,
- Unilateral or bilateral lower extremity amputation.
- Rest pain (e.g., Rutherford category 4 or greater), documented untreated iliac or common femoral artery diameter stenosis > 50% or previous bypass surgery/stent placement in the common femoral artery of target leg,
- Known existing nerve damage in the target leg,
- Known allergy to any of the materials used in the PerQseal® device (refer to Instructions for Use),
- Subject unsuitable for surgical repair of the target leg access site,
- Subject has undergone a percutaneous procedure greater than 8 F sheath in the target leg, within the 90 days prior to index procedure,
- Subject has undergone a percutaneous procedure of 8 F sheath or less using an absorbable or suture mediated closure device for hemostasis, in the target vessel, within the 90 days prior to index procedure,
- Prior evidence of anterior calcification within 10 mm proximal or distal to arteriotomy site,
- Target femoral artery diameter is less than 6 mm in diameter,
- Subject is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up,
- Subject has been previously enrolled in this clinical study.
- Current COVID-19 infection (with or without symptoms), recent positive test for COVID-19, or recent exposure to a person with COVID-19 infection.
- Procedural Exclusion Criteria:
- Initial common femoral arterial access achieved with manual palpation or blind arterial stick access, without use of an image guided approach (ultrasound or angiography).
- Difficult dilation during initial target femoral artery access (e.g., that damages or kinks sheath dilators) while step-dilating up to the large-bore device,
- During arterial puncture, the target femoral artery suspected to have experienced a back arterial wall needle puncture or underwent > one needle puncture during the primary procedure,with a needle larger than a Micropuncture needle (18 gauge)
- Subject has a tissue tract (i.e., estimated distance from skin entry point to arterial anterior surface at arteriotomy) expected to be greater than 8 cm,
- Significant blood loss/transfusion (defined as requiring transfusion of 4 or more units of blood products) during primary procedure or within 30 days prior to index procedure,
- Activated clotting time (ACT) > 300 seconds immediately prior to sheath removal or if ACT measurements are expected to be > 300 seconds for more than 24 hours after index procedure,
- Target puncture site is in a vascular graft,
- Target arteriotomy in the profunda femoris or superficial femoral artery or is in common femoral artery, but within 10 mm proximal of the bifurcation of the superficial femoral/ profunda femoris artery,
- Target arteriotomy located above the inferior epigastric artery and/or above the inguinal ligament based on bony landmarks,
- Subjects with an acute hematoma > 4 cm diameter, arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the target access site,
- Evidence of bleeding around the Impella sheath (BARC type 2 or higher),
- Angiographic evidence of arterial laceration, dissection or stenosis within the femoral artery that would preclude use of the PerQseal® device,
- Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) just prior to planned vascular closure.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Buffalo
Buffalo, New York, 14203
The Valley Hospital
Ridgewood, New Jersey, 07450
Stony Brook University Hospital
Stony Brook, New York, 11794
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Early Feasibility Study of the Vivasure PerQseal® Closure Device System After Use of the Impella Device for Cardiogenic Shock or Protected Percutaneous Coronary Intervention
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.
Read the detailed description
This study is a prospective, multi-center, single arm EFS. Patients undergoing use of an Impella device for cardiogenic shock or PPCI, requiring an arteriotomy created by 13 to 14 F sheaths (arteriotomies up to approx. 18 F), via the common femoral artery will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provide informed consent, and shall subsequently be assigned a study ID number. Enrollment will occur at the point where the PerQseal study device first enters the patient's body.
The planned enrollment is a minimum of 20 treated patients at a maximum of 5 study sites located in the United States.
- Conditions
- Percutaneous Large Hole Vascular Closure
- Being tested
- PPCI, Cardiogenic shock
- Keywords
- vascular closure, arterial closure, vascular closure device, large hole percutaneous closure, large bore percutaneous closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPCIDevice
Also called Percutaneous PerQseal device closure
Closure of the femoral access site with PerQseal device at the end of the PPCI index procedure and removal of the Impella pump.
Cardiogenic shockDevice
Also called Percutaneous PerQseal device closure
Closure of the femoral access site with PerQseal device after removal of the Impella pump.
| Study group | Role | What they receive |
|---|---|---|
| Protected Percutaneous Coronary Intervention | Experimental | 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. Receives: Device: PPCI |
| Cardiogenic shock | Experimental | 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. Receives: Device: Cardiogenic shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Major Access Site Complications
The primary safety endpoint is the rate of major access site complications attributable to the PerQseal® device. As per FDA definitions for Major access site complications.
Measured: through 30 days
Efficacy: Time to Hemostasis
Elapsed time in minutes from PerQseal® Introducer sheath removal to first observed cessation of common femoral artery (CFA) bleeding (excluding cutaneous or subcutaneous oozing, and in the absence of a developing hematoma).
Measured: 20 minutes
Secondary outcomes (5)
Safety: Incidence of Minor Access Site Complications
Incidence and severity of minor access site complications attributable to the PerQseal® device, adapted from FDA-provided definitions.
Measured: through 30 days
Efficacy: PerQseal® Device Technical Success Rate
PerQseal® Device Technical Success Rate, defined as the number of PerQseal® devices that are deployed and achieve hemostasis (i.e., cessation of bleeding (excluding cutaneous or subcutaneous oozing)) without need for firm, adjunctive manual compression for greater than 10 minutes or alternative treatment (other than adjunctive endovascular ballooning) at target access site, divided by the total number of PerQseal® devices where deployment was attempted.
Measured: 10 minutes
Efficacy: PerQseal® Treatment Success Rate
PerQseal® Treatment Success Rate, defined as the number of subjects who meet PerQseal® Device Technical Success without experiencing a Major Access Site Complication, divided by the total number of subjects where PerQseal® device deployment was attempted.
Measured: through 30 days
Efficacy: Time to Device Deployment
Time to Device Deployment, defined as the time from insertion of the PerQseal® device into the PerQseal Introducer sheath to complete removal of the PerQseal® device delivery system and PerQseal® Introducer sheath from the subject following PerQseal® deployment.
Measured: 20 minutes
Efficacy: Overall Procedural Time
Overall Procedural Time, defined as the time from first invasive contact with the subject's groin to completion of all aseptic procedures related to the groin and index procedure.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start29 Jun 2021
- Primary completion1 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Large Hole Vascular ClosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Early Feasibility Study
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivasure Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818541
- Sponsor's protocol ID
- P849-00
- Status last verified
- Apr 2023
- First submitted
- 25 Mar 2021
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Vivasure PerQseal® Closure Device System After Use of the Impella Device for Cardiogenic Shock or Protected Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04818541
- Acronym / sponsor ID
- P849-00
- Conditions
- Percutaneous Large Hole Vascular Closure
- Keywords
- vascular closure, arterial closure, vascular closure device, large hole percutaneous closure, large bore percutaneous closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vivasure Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, multi-center, single arm EFS. Patients undergoing use of an Impella device for cardiogenic shock or PPCI, requiring an arteriotomy created by 13 to 14 F sheaths (arteriotomies up to approx. 18 F), via the common femoral artery will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provide informed consent, and shall subsequently be assigned a study ID number. Enrollment will occur at the point where the PerQseal study device first enters the patient's body.
The planned enrollment is a minimum of 20 treated patients at a maximum of 5 study sites located in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Early Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| Protected Percutaneous Coronary Intervention | Experimental | Device: PPCISubjects 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. |
| Cardiogenic shock | Experimental | Device: Cardiogenic shockSubjects 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- 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,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPCIAlso: Percutaneous PerQseal device closureClosure of the femoral access site with PerQseal device at the end of the PPCI index procedure and removal of the Impella pump. | Device | Protected Percutaneous Coronary Intervention |
| Cardiogenic shockAlso: Percutaneous PerQseal device closureClosure of the femoral access site with PerQseal device after removal of the Impella pump. | Device | Cardiogenic shock |
Primary outcome
Safety: Major Access Site Complications
Time frame: through 30 days
The primary safety endpoint is the rate of major access site complications attributable to the PerQseal® device. As per FDA definitions for Major access site complications.
Efficacy: Time to Hemostasis
Time frame: 20 minutes
Elapsed time in minutes from PerQseal® Introducer sheath removal to first observed cessation of common femoral artery (CFA) bleeding (excluding cutaneous or subcutaneous oozing, and in the absence of a developing hematoma).
5 secondary outcomes
Safety: Incidence of Minor Access Site Complications
Time frame: through 30 days
Efficacy: PerQseal® Device Technical Success Rate
Time frame: 10 minutes
Efficacy: PerQseal® Treatment Success Rate
Time frame: through 30 days
Efficacy: Time to Device Deployment
Time frame: 20 minutes
Efficacy: Overall Procedural Time
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPCI and Cardiogenic shock in people with Percutaneous Large Hole Vascular Closure, run by Vivasure Medical Limited at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Major Access Site Complications (time frame: through 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.