PerQseal®+ Early Feasibility Study

NCT05163548 | Completed DMC FDA Device

• 1 other identifier: P856-00
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of this Early Feasibility Study (EFS) is to evaluate the initial safety and preliminary effectiveness of the PerQseal®+ VCD in a small number of subjects when used to achieve hemostasis of common femoral arteriotomies created by 14 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing Percutaneous Transcatheter 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)

• 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.

  though 30 days

• Efficacy: Time to Haemostasis

  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).

  20 minutes

Secondary Outcomes (6)

• Safety: Incidence of Minor Access Site Complications

  through 30 days

• Efficacy: PerQseal® Device Technical Success Rate

  10 minutes

• Efficacy: PerQseal® Treatment Success Rate

  through 30 days

• Efficacy: Time to Device Deployment

  20 minutes

• Efficacy: Time to Ambulation

  through 5 day

Study Arms (1)

Subjects that receive PerQseal Plus Device

EXPERIMENTAL

Subjects undergoing large hole endovascular percutaneous procedures with a femoral arteriotomy created with 14 to 22 F sheaths (arteriotomy up to 26 F)

Device: PerQseal Plus Device

Interventions

PerQseal Plus Device DEVICE

Percutaneous closure of femoral artery access site created by 14 to 22 F sheaths (up to 26 F arteriotomy) in patients undergoing Percutaneous Transcatheter procedures.

Also known as: Vascular Closure Device

Subjects that receive PerQseal Plus 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, 2. Clinically indicated for a large bore interventional transcatheter procedure, e.g., transcatheter aortic valve repair (TAVR) or endovascular abdominal aortic aneurysm repair (EVAR), or thoracic endovascular aneurysm repair (TEVAR) using a percutaneous common femoral arteriotomy created by a 14 to 22 F sheath, 3. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements, 4. 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 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,
• NYHA functional class IV heart failure that is uncontrolled and requires treatment in the Intensive Care Unit, within 24 hours prior to primary procedure,
• Documented left ventricular ejection fraction \< 20%,
• Unilateral or bilateral lower extremity amputation.
• Claudication (e.g., 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 use of an intra-aortic balloon pump through the target leg access site within 90 days prior to the index procedure,
• Subject has undergone a percutaneous procedure of 8 F sheath or less using an absorbable intravascular closure device for hemostasis, in the target vessel, within the 90 days prior to index procedure,

Sponsors & Collaborators

• Vivasure Medical Limited: lead

Study Sites (5)

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Montefiore Hospital

The Bronx, New York, 10467, United States

Location

Lankenau Heart Institute

Wynnewood, Pennsylvania, 10032, United States

Location

MeSH Terms

Interventions

Vascular Closure Devices

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

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

Model Details: Early Feasibility Study

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 20, 2021
• Study Start: March 8, 2022
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)