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

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

NCT02406612•Essential Medical, Inc.

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+20 more criteria

Locations (2)

University of Lubeck Hospital

Lübeck, Germany

University of Rostock Hosptial

Rostock, Germany

Key Dates

Start Date

April 1, 2015

Primary Completion Date

February 1, 2016

Completion Date

June 1, 2016

Last Updated

October 29, 2018

Enrollment

ACTUAL participants

Conditions

Femoral Arteriotomy Closure

Interventions

X-Seal 6F Vascular Closure Device

DEVICE

The Ladera Suture-Mediated Large Bore Closure Study

NCT06851481

Vascular ClosureFemoral Arteriotomy Closure

View study

ACTIVE_NOT_RECRUITINGNA

The Ladera Large Bore Closure Feasibility Study

NCT06358157

Vascular ClosureFemoral Arteriotomy Closure

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Ladera Suture-Mediated Large Bore Closure Study

The Ladera Large Bore Closure Feasibility Study

Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device