PerQseal® Elite Venous Clinical Study (ELITE-Venous)

NCT06007339 | Recruiting DMC

• 1 other identifier: P934-00
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F) in patients undergoing percutaneous catheter-based interventional procedures, with sufficient rigor to provide robust scientific evidence for the demonstration of clinical safety and efficacy of the PerQseal Elite closure system to support a CE-mark and a PMA submission.

Conditions

Large Hole Percutaneous Venous Closure

Keywords

Venous Closure; Percutaneous closure; Large bore closure

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint- Combined rate of both Major and Minor access site complications

  the combined rate of both Major and Minor access site complications attributable to the PerQseal Elite device§ through 30-days, as adjudicated by the Clinical Events Committee (CEC) as study device related.

  through 30 Days

• Primary Effectiveness Endpoint - Time to Haemostasis

  Time to Haemostasis (TTH) defined as elapsed time in minutes from PerQseal Elite (Introducer-sheath and Delivery-device) removal to first observed cessation of common femoral vein (CFV) bleeding (clinically acceptable cessation of venous bleeding), excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma. This is assessed at the end of the index procedure prior leaving the operating room/catheterisation laboratory.

  20 Minutes

Secondary Outcomes (5)

• Secondary Effectiveness Endpoint - PerQseal Elite Technical Success Rate

  10 Minutes

• Secondary Effectiveness Endpoint - PerQseal Elite Treatment Success Rate

  through 30 days

• Secondary Effectiveness Endpoint -Time to Device Deployment (TTDD)

  20 Minutes

• Secondary Effectiveness Endpoint - Time to Ambulation

  through 24 hours

• Secondary Effectiveness Endpoint - Total Closure Time

  40 Minutes

Study Arms (1)

Investigational Device Arm (PerQseal Elite- Venous)

EXPERIMENTAL

Large hole percutaneous venous closure device - PerQseal Elite

Device: PerQseal ELITE

Interventions

PerQseal ELITE DEVICE

The term PerQseal Elite used singularly refers to the closure system comprising the closure device and Introducer. These individually are referred to as: "PerQseal Elite VCD" or "PerQseal Elite closure device" and/or "PerQseal Elite Introducer".

Also known as: Percutaneous ELITE Venous Closure Device

Investigational Device Arm (PerQseal Elite- Venous)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years.
• Clinically indicated for a percutaneous venous interventional catheter-based procedure, e.g., mitral valve edge to edge repair, left atrial appendage device closure, leadless pacemaker implantation, patent foramen ovale closure or use of a circulatory assist device or extracorporeal oxygenation using a common femoral venotomy created by a 14 to 22F sheath (venotomy up to 26F).
• 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, unstable INR, definite or potential coagulopathy, platelet count \< 100,000/μl or subjects on long term anticoagulants with an INR \> 2.2 within 12 hours prior to index procedure,
• Significant anaemia (example: haemoglobin \< 8 g/dL or haematocrit \< 22%), within 24 hours prior to index procedure,
• Known type II heparin-induced thrombocytopenia,
• Documented right ventricular dysfunction \< 13%,
• Ipsilateral or contralateral lower extremity amputation,
• Previous groin surgery within the region of the ipsilateral vessel access,
• Common femoral vein diameter stenosis \> 50% or previous bypass surgery/stent placement in the common femoral vein of target leg,
• Known existing nerve damage in the target leg,
• Nephrotic syndrome or renal insufficiency (Glomerular Filtration Rate ≤ 30 ml/min or baseline serum creatinine \> 2.5 mg/dl) or on renal replacement therapy or albumin level \< 3.5 g/dl or symptoms of pitting oedema,
• Systolic pulmonary artery pressure \> 60 mmHg
• Known allergy to any of the materials used in the PerQseal Elite device (refer to Investigator's Brochure),
• Subject is unsuitable for surgical repair of the target leg access site,
• Subject has undergone a percutaneous procedure greater than 8F sheath in the target vessel, within the 90-days prior to index procedure,
• Subject has undergone a percutaneous procedure of 8F sheath or less using an absorbable intravascular closure device for haemostasis, in the target vessel, within the 90-days prior to index procedure,

Sponsors & Collaborators

• Vivasure Medical Limited: lead

Study Sites (1)

Erasmus UMC

Rotterdam, Rotterdam, Netherlands

RECRUITING

Central Study Contacts

Chris Martin

CONTACT

+353 91 395 442; Chris.Martin@vsuremed.com

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: This study is a prospective, multicentre, single-arm study to investigate the safety and efficacy of the PerQseal Elite.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: April 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)