X-Seal EU Post-Market Clinical Follow-Up Protocol

X-Seal 6F Vascular Closure Device EU Post-Market Clinical Follow-Up Protocol

The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone diagnostic or interventional catheterization procedures using up to 6F sheaths when compared with standard compression techniques using data from literature surveys.

Study Overview

• Status: Completed
• Conditions: Femoral Arteriotomy Closure
• Intervention / Treatment: Device: X-Seal 6F Vascular Closure Device

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lubeck, Germany
    • University of Lubeck Hospital
  • Rostock, Germany
    • University of Rostock Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Candidate for non-emergent diagnostic or interventional cardiac catheterization via a femoral sheath ≤6F.
• Age ≥18 years.
• Understand and sign the study specific written informed consent form.
• In the investigator's opinion, the patient is suitable for the X-Seal vascular closure device, conventional hemostasis techniques and participation in an investigational trial.
• Eligible for sheath removal in the catheterization lab.

Exclusion Criteria:

• Patients who are known to be pregnant or lactating.
• Patients who are immunocompromised.
• Prior target artery closure with any vascular closure device or closure with manual compression win 30 days prior to this procedure.
• Patients with significant anemia (hemoglobin <10 g/DL, Hct<30).
• Patients who are morbidly obese or cachectic (BMI >40 or <20 kg/m2).
• Patients with Systolic Blood Pressure >180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure
• Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period.
• Patients with a baseline INR > 1.5 (e.g. coumadin therapy).
• Patients with a known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand's disease.
• Patients with small femoral arteries (<4 mm), femoral artery stenosis resulting in a vessel diameter <4 mm, or patients with severe peripheral vascular disease.
• Patients with puncture site believed to be in the profunda femoris, superficial femoral artery, or at the bifurcation of the arteries.
• Common femoral artery with fluoroscopically visible calcium.
• Femoral arteries that are suspected to have experienced a back wall puncture or that underwent >one (1) arterial puncture during the catheterization procedure.
• Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula.
• Patients in whom continued heparin or other anticoagulant/antiplatelet therapy is planned (with the exception of Glycoprotein IIb/IIIa receptor blockers) following completion of the catheterization procedure.
• Patients whose ACT is >300 seconds prior to removal of the guiding catheter.
• Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence or life threatening disease.
• Prior femoral vascular surgery or vascular graft in region of access site.
• Patient is unable to ambulate at baseline.
• Acute ST-elevation MI within 48 hours prior to procedure.
• Active systemic or cutaneous infection or inflammation
• Patients with unilateral or bilateral lower extremity amputation
• Patients with renal insufficiency (serum creatinine >2.5 mg/dl)
• Patients with marked tortuosity of the femoral or iliac artery
• Patients in whom bacterial contamination of the procedure sheath or surrounding tissues may have occurred as this may result in infection
• Patients in whom the puncture site is located above the most inferior border of the epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma/bleed. Perform a femoral angiogram to verify the location of the puncture site
• Patients with known allergies to beef products, collagen and/or collagen products, or polyglycolic or polylactic acid polymers
• Patients with known allergy to stainless steel or nickel. See MRI information in the IFU.
• Patients undergoing therapeutic thrombolysis
• Patients punctured through a vascular graft

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: X-Seal 6F Vascular Closure Device; The X-Seal 6F Vascular Closure device will be used to achieve hemostasis in both diagnostic and interventional procedures using up to a 6F procedure sheath.	Device: X-Seal 6F Vascular Closure Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Complications	The rate of major complications within approximately 30 days following the procedure.	30 days
Time-to-Hemostasis	Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding.	Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-Ambulation	The time from end of the procedure until the patient ambulates for the first time.	Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients.
Adverse Events	The rate of adverse events within approximately 30 days following the procedure. All AEs counted, whether or not device-related.	30 days

Collaborators and Investigators

• Sponsor: Essential Medical, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Vascular Closure Device; Femoral Artery Closure
• Other Study ID Numbers: PSD-028