Clinical Study of the Medeon Biodesign XPro™

Prospective, Multi-Center, Single Arm Study of the Medeon Biodesign XPro™ Suture-Mediated Vascular Closure Device System

To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.

Study Overview

• Status: Completed
• Conditions: Percutaneous Closure of Arteriotomy in Common Femoral Artery
• Intervention / Treatment: Device: XPro System

Detailed Description

This is a prospective multi-center, single arm study to assess the safety and performance of the XPro System compared to a historical control developed from published studies of two marketed competitive devices, Perclose ProGlide® and Prostar® XL (both from Abbott Vascular, Inc., Redwood City, CA, USA). The goal of the study is to show that XPro System is non-inferior to the competitors in efficacy and safety. Patients scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR procedures using an 8-18 Fr introducer sheath will be screened for study eligibility. Patients will be followed for 30 days post procedure.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St. Vincent's Hospital Melbourne
• New Zealand
  • Auckland, New Zealand, 1142
    • Auckland City Hospital
  • Christchurch, New Zealand, 4710
    • Christchurch Hosptial
  • Hamilton, New Zealand
    • Waikato Hospital
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is > 18 years old
• Patient is scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR involving access through the femoral artery using an 8-18 Fr introducer sheath
• Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
• Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
• Patient is willing and able to complete follow-up

Exclusion Criteria:

• Prior intra-aortic balloon pump at access site
• Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%
• Common femoral artery lumen diameter is < 6 mm
• Prior target artery closure with any closure device < 90 days, or closure with manual compression ≤ 30 days prior to index procedure
• Prior vascular surgery, vascular graft, or stent in region of access site
• Patients receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
• Patients with significant anemia ((Hgb < 10 g/dL, Hct < 30%)
• Patient with known bleeding disorder including thrombocytopenia (platelet count < 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
• Patients with renal insufficiency (serum creatinine level > 221µmol/L) or renal transplant
• Known allergy to contrast reagent
• Inability to tolerate aspirin and/or other anticoagulation treatment
• Planned anticoagulation therapy post-procedure such that ACT is expected to be elevated above 350 seconds for more than 24 hours after the procedure
• Connective tissue disease (e.g., Marfan's Syndrome)
• Thrombolytics (e.g. t-PA, streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure
• Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
• Patients who are morbidly obese BMI > 40 kg/m2
• Planned major intervention or surgery within 30 days following the interventional procedure
• Patients who are unable to ambulate at baseline
• Currently participating in a clinical study of an investigational device or drug that has not completed study endpoint
• Known allergy to any device component
• Patient is known or suspected to be pregnant or lactating
• Life expectancy < 1 year as judged by the investigator
• Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating Intra-Procedure
• Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
• Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
• Ipsilateral femoral venous sheath during the catheterization procedure
• Common femoral artery calcium, which is fluoroscopically visible
• Patients where there is difficulty inserting the introducer sheath or greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure
• Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
• Evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site
• Patients with intra-procedural bleeding around access site
• Evidence of active systemic or local groin infection
• Patients receiving glycoprotein IIb/IIIa inhibitors during, or after the catheterization procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: XPro System; Implantation of XPro System during percutaneous vascular closure	Device: XPro System; Implantation of the XPro System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hemostasis	Time to hemostasis absent of any access-site-related adjunctive surgical or endovascular procedures.	15 minutes
Freedom from major VARC-2 events	Freedom from major VARC-2 events within 30 days of the procedure.	Up to 30 days of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from minor VARC-2 events	Freedom from minor VARC-2 events up to 30 days of the procedure.	Up to 30 days of procedure
Successful hemostasis with the XPro System	Without the need for any access-site-related adjunctive surgical or endovascular procedures and freedom from major VARC-2 events.	at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure
Freedom from access-site infection	Freedom from access-site infection requiring IV or IM antibiotics, or extended hospitalization or re-hospitalization.	Up to 30 days of procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to ambulation	Defined as elapsed time from sheath removal and time when the patient stands and walks at least 20 feet without re-bleeding.	Up to 48 hours
Time to hospital discharge	Time to actual hospital discharge defined as elapsed time from sheath removal to actual physical discharge from the hospital.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: Medeon Biodesign, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2017
• Primary Completion (Actual): July 25, 2019
• Study Completion (Actual): September 12, 2019

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CIP-LHC03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No