Clinical Study of the Medeon Biodesign XPro™

NCT03171155 | Completed

• 1 other identifier: CIP-LHC03
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 6

Brief Summary

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.

Conditions

Percutaneous Closure of Arteriotomy in Common Femoral Artery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Freedom from minor VARC-2 events

  Up to 30 days of procedure

• Successful hemostasis with the XPro System

  at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure

• Freedom from access-site infection

  Up to 30 days of procedure

Other Outcomes (2)

• Time to ambulation

  Up to 48 hours

• Time to hospital discharge

  Up to 2 weeks

Study Arms (1)

XPro System

EXPERIMENTAL

Implantation of XPro System during percutaneous vascular closure

Device: XPro System

Interventions

XPro System DEVICE

Implantation of the XPro System

XPro System

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medeon Biodesign, Inc.: lead

Study Sites (6)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Auckland City Hospital

Auckland, 1142, New Zealand

Location

Christchurch Hosptial

Christchurch, 4710, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Study Design

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

Model Details: Implantation of the XPro System

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 31, 2017
• Study Start: May 25, 2017
• Primary Completion: July 25, 2019
• Study Completion: September 12, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (3); TW (1); AU (2)