Safety and Performance Study for Arterial Large Hole Vascular Closure Device

NCT05951634 | Unknown DMC

• 1 other identifier: P935-00
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 14 to 22 F sheaths. Note, for reference purposes, it is expected arteriotomies created with 14 to 22 F sheaths will create an arteriotomy in the range of 16 - 26 F (being the outer diameter of these sheaths).

Conditions

Large Hole Percutaneous Arterial Closure

Keywords

Arterial closure; Percutaneous arterial closure; Large hole arterial closure; Large bore arterial closure

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint - Major access site complications

  Rate of major access site complications attributable to the PerQseal Elite device

  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 artery (CFA) bleeding, excluding cutaneous or subcutaneous oozing, and in the absence of a developing haematoma.

  20 Minutes

Secondary Outcomes (6)

• Secondary Safety Endpoint - Incidence of Minor Access Site Complications

  Through 30 Days

• 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

  20 Minutes

• Secondary Effectiveness Endpoint - Time to Ambulation

  through 24 hours

Study Arms (1)

Investigational Device Arm (PerQseal Elite)

EXPERIMENTAL

Large hole percutaneous arterial closure device - PerQseal Elite

Device: PerQseal ELITE

Interventions

PerQseal ELITE DEVICE

Percutaneous ELITE Arterial Closure 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".

Investigational Device Arm (PerQseal Elite)

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 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 14 to 22F sheath (arteriotomy 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, 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 (example: 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,
• Previous groin surgery within the region of the ipsilateral access,
• 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 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 leg, 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 leg, within the 90-days prior to index procedure,
• Subject has undergone a percutaneous procedure of 8F 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,

Sponsors & Collaborators

• Vivasure Medical Limited: lead

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: June 29, 2023
• First Posted: July 19, 2023
• Study Start: August 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share