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

NCT02406612 | Completed Results

• 1 other identifier: PSD-028
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Femoral Arteriotomy Closure

Keywords

Vascular Closure Device; Femoral Artery Closure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Time-to-Ambulation

  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

  30 days

Study Arms (1)

X-Seal 6F Vascular Closure Device

EXPERIMENTAL

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

Interventions

X-Seal 6F Vascular Closure Device DEVICE

X-Seal 6F Vascular Closure Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Essential Medical, Inc.: lead

Study Sites (2)

University of Lubeck Hospital

Lübeck, Germany

Location

University of Rostock Hosptial

Rostock, Germany

Location

Results Point of Contact

• Title: Sam Nardone
• Organization: Essential Medical

sam@essmedclosure.com

6105571009

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 2, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-01

Locations

DE (2)