PerQseal® Clinical Study

NCT05653336 | Active Not Recruiting DMC FDA Device

• 1 other identifier: P696-00
• Study Type: interventional
• Target: 149
• Locations: 2 countries
• Sites: 18

Brief Summary

The objective is to evaluate the safety and effectiveness of the PerQseal vascular closure device system when used to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing percutaneous catheter-based interventional procedures.

Conditions

Percutaneous Large Hole Vascular Closure

Keywords

Vascular Closure; Vascular Closure Device; Large hole percutaneous closure; Large bore percutaneous closure

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint - Major Access Site Complications

  Rate of major access site complications attributable to the PerQseal device

  through 30 days

• Primary Effectiveness Endpoint - Time to Hemostasis

  Elapsed time in minutes from PerQseal (Introducer-sheath and Delivery Device) removal to first observed cessation of common femoral artery (CFA) bleeding, excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma.

  20 Minutes

Secondary Outcomes (6)

• Secondary Safety Endpoint - Minor Access Site Complications

  through 30 Days

• Secondary Effectiveness Endpoint - PerQseal Technical Success Rate

  10 Minutes

• Secondary Effectiveness Endpoint - PerQseal Treatment Success Rate

  through 30 days

• Secondary Effectiveness Endpoint - Time to Device Deployment

  20 Minutes

• Secondary Effectiveness Endpoint - Time to Ambulation

  through 24 hours

Study Arms (1)

Subjects implanted with PerQseal Vascular Closure Device

EXPERIMENTAL

Subjects implanted with bioabsorbable implant to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (up to 26 F arteriotomy) in patients undergoing percutaneous catheter-based interventional procedures.

Device: PerQseal® Closure Device System

Interventions

PerQseal® Closure Device System DEVICE

Bioabsorbable implant delivered percutaneously to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (up to 26 F arteriotomy) in patients undergoing percutaneous catheter-based interventional procedures.

Subjects implanted with PerQseal Vascular Closure Device

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years,
• Clinically indicated for a percutaneous arterial interventional catheter-based procedure, e.g., transcatheter aortic valve replacement/implantation (TAVR/TAVI) or endovascular abdominal aortic aneurysm repair (EVAR), or thoracic endovascular aortic aneurysm repair (TEVAR), or use of a circulatory assist device or extracorporeal oxygenation using a common femoral arteriotomy created by a 12 to 22 F sheath (arteriotomy up to 26 F),
• Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements,
• Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.

You may not qualify if:

• Evidence of current 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 anaemia (haemoglobin \< 9 g/dL or haematocrit \< 27%), within 24 hours prior to index procedure,
• Known type II heparin-induced thrombocytopenia,
• Documented left ventricular ejection fraction \< 20%,
• Ipsilateral or contralateral lower extremity amputation.
• Claudication (Rutherford category 3 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,
• Renal insufficiency (Glomerular Filtration Rate ≤ 30 ml/min or baseline serum creatinine \> 2.5 mg/dL) or on renal replacement therapy,
• 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 intravascular closure device for haemostasis, 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 a suture mediated closure device or manual/mechanical pressure for haemostasis in the target leg, within the 30-days prior to index procedure,
• Evidence of marked tortuosity of the femoral or external iliac arteries in the target leg, based on pre-primary procedure CT angiography,

Sponsors & Collaborators

• Vivasure Medical Limited: lead

Study Sites (18)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Scripps

La Jolla, California, 92037, United States

Location

Northern Light Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Columbia University Medical Center/ NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14623, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center (multiple centers)

The Bronx, New York, 10461, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

UPMC Pinnacle Health

Mechanicsburg, Pennsylvania, 17050, United States

Location

UPenn - Perelman Center for Advanced Medicine,

Philadelphia, Pennsylvania, 19104, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

The Texas Heart Institute

Houston, Texas, 77030, United States

Location

St Franziskus Hospital

Münster, North Rhine-Westphalia, Germany

Location

Leipzig University Hospital

Leipzig, Saxony, 04103, Germany

Location

St. Gertrauden Krankenhaus (SGK)

Berlin, 10713, Germany

Location

Study Officials

• William Gray, Dr.

  Lankenau heart Institute

  PRINCIPAL INVESTIGATOR

• Sean Lyden, Dr.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 16, 2022
• Study Start: March 30, 2023
• Primary Completion: December 16, 2024
• Study Completion: June 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); DE (3)