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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03171155




Registration number
NCT03171155
Ethics application status
Date submitted
23/05/2017
Date registered
31/05/2017
Date last updated
30/04/2019

Titles & IDs
Public title
Clinical Study of the Medeon Biodesign XPro™
Scientific title
Prospective, Multi-Center, Single Arm Study of the Medeon Biodesign XPro™ Suture-Mediated Vascular Closure Device System
Secondary ID [1] 0 0
CIP-LHC03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Percutaneous Closure of Arteriotomy in Common Femoral Artery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - XPro System

Experimental: XPro System - Implantation of XPro System during percutaneous vascular closure


Treatment: Devices: XPro System
Implantation of the XPro System

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Hemostasis - Time to hemostasis absent of any access-site-related adjunctive surgical or endovascular procedures.
Timepoint [1] 0 0
15 minutes
Primary outcome [2] 0 0
Freedom from major VARC-2 events - Freedom from major VARC-2 events within 30 days of the procedure.
Timepoint [2] 0 0
Up to 30 days of procedure
Secondary outcome [1] 0 0
Freedom from minor VARC-2 events - Freedom from minor VARC-2 events up to 30 days of the procedure.
Timepoint [1] 0 0
Up to 30 days of procedure
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure
Secondary outcome [3] 0 0
Freedom from access-site infection - Freedom from access-site infection requiring IV or IM antibiotics, or extended hospitalization or re-hospitalization.
Timepoint [3] 0 0
Up to 30 days of procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medeon Biodesign, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03171155
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amy Forro, BS
Address 0 0
Country 0 0
Phone 0 0
508-254-1005
Fax 0 0
Email 0 0
aforro@linceconsulting.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03171155