Status:
RECRUITING
PerQseal® Elite Venous Clinical Study (ELITE-Venous)
Lead Sponsor:
Vivasure Medical Limited
Conditions:
Large Hole Percutaneous Venous Closure
Eligibility:
All Genders
19+ years
Phase:
NA
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...
Detailed Description
This study is a prospective, multicentre, single-arm study to investigate the safety and efficacy of the PerQseal Elite in up to 97 patients at up to 12 European investigational sites. The study shall...
Eligibility Criteria
Inclusion
- 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.
- Baseline
Exclusion
- 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,
- 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 vessel, within the 30-days prior to index procedure,
- History of DVT or pulmonary embolism or venous thrombotic event,
- Splenectomy or suffering psoriasis or paraesthesia of the ipsilateral leg,
- Further planned endovascular/catheter-based procedure in the target leg in the 30-days following the index procedure,
- Subject is enrolled in another investigational medical device or drug study,
- Subject has been previously enrolled in this clinical study,
- Subject is unable to maintain ipsilateral leg still during the index procedure (restless leg syndrome),
- Current COVID-19 infection (with or without symptoms), recent positive test for COVID-19 within two weeks, or recent exposure to a person with COVID-19 infection within two weeks.
- Procedural
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06007339
Start Date
April 1 2024
End Date
December 1 2025
Last Update
March 26 2025
Active Locations (1)
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1
Erasmus UMC
Rotterdam, Rotterdam, Netherlands