Actively Recruiting
PerQseal® Elite Venous Clinical Study (ELITE-Venous)
Led by Vivasure Medical Limited · Updated on 2025-03-26
90
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PerQseal® Elite Venous Clinical Study (ELITE-Venous)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Clinically indicated for a percutaneous venous catheter-based procedure requiring a common femoral venotomy created by 14 to 22F sheaths (venotomy up to 26F)
- Willing and able to provide informed consent and comply with study procedures and follow-up
- Females must not be pregnant, lactating, or planning pregnancy during the study period
You will not qualify if you...
- Current systemic bacterial or skin infection, including groin infection
- Known bleeding disorders or unstable blood clotting measures
- Significant anemia (hemoglobin < 8 g/dL or hematocrit < 22%) within 24 hours before procedure
- Known type II heparin-induced thrombocytopenia
- Documented right ventricular dysfunction less than 13%
- Ipsilateral or contralateral lower limb amputation
- Previous groin surgery on the same side as access site
- Common femoral vein stenosis over 50% or previous bypass/stent in target vein
- Known nerve damage in target leg
- Severe kidney disease or nephrotic syndrome
- Pulmonary artery pressure over 60 mmHg
- Allergy to materials in the PerQseal Elite device
- Unsuitable for surgical repair at access site
- Percutaneous procedures in target vessel within 90 days exceeding 8F sheath
- History of deep vein thrombosis, pulmonary embolism, or venous thrombosis
- Splenectomy, psoriasis, or numbness in target leg
- Planned further endovascular procedures in target leg within 30 days after index procedure
- Participation in another investigational drug or device study
- Prior enrollment in this study
- Inability to keep leg still during procedure
- Current or recent COVID-19 infection or exposure
- Anatomical or procedural issues affecting femoral vein access suitability
- Significant blood loss requiring transfusion within 30 days before procedure
- Activated clotting time over 250 seconds before sheath removal
- Target puncture site in vascular graft
- Target venotomy size greater than 26F
- Femoral vein diameter less than 7 mm
- Venous stenosis over 20% near venotomy
- Venotomy location not in common femoral vein or outside specified anatomical landmarks
- Acute hematoma larger than 4 cm, arteriovenous fistula, pseudoaneurysm, or thrombosis at access site
- Bleeding around primary procedure sheath (VARC type 1/BARC type 2 or higher)
- Venous laceration, dissection, or stenosis preventing use of PerQseal Elite device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Erasmus UMC
Rotterdam, Rotterdam, Netherlands
Actively Recruiting
Research Team
C
Chris Martin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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