Percutaneous Closure of Arteriotomy in Common Femoral ArteryNCT03171155
Clinical Study of the Medeon Biodesign XPro™
A study testing XPro System in people with Percutaneous Closure of Arteriotomy in Common Femoral Artery, run by Medeon Biodesign, Inc. at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Closure of Arteriotomy in Common Femoral Artery
- What is being tested?
- XPro System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 25 May 2017to 12 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
New Zealand3 sites
Auckland City Hospital
Auckland, 1142
Christchurch Hosptial
Christchurch, 4710
Waikato Hospital
Hamilton
Australia2 sites
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
Official title: 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.
Read the 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.
- Being tested
- XPro System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPro SystemDevice
Implantation of the XPro System
| Study group | Role | What they receive |
|---|---|---|
| XPro System | Experimental | Implantation of XPro System during percutaneous vascular closure Receives: Device: XPro System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hemostasis
Time to hemostasis absent of any access-site-related adjunctive surgical or endovascular procedures.
Measured: 15 minutes
Freedom from major VARC-2 events
Freedom from major VARC-2 events within 30 days of the procedure.
Measured: Up to 30 days of procedure
Secondary outcomes (3)
Freedom from minor VARC-2 events
Freedom from minor VARC-2 events up to 30 days of the procedure.
Measured: 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.
Measured: 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.
Measured: Up to 30 days of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start25 May 2017
- Primary completion25 Jul 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Closure of Arteriotomy in Common Femoral ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Implantation of the XPro System
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medeon Biodesign, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171155
- Sponsor's protocol ID
- CIP-LHC03
- Status last verified
- Sep 2019
- First submitted
- 23 May 2017
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Single Arm Study of the Medeon Biodesign XPro™ Suture-Mediated Vascular Closure Device System
- ClinicalTrials.gov ID
- NCT03171155
- Acronym / sponsor ID
- CIP-LHC03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Medeon Biodesign, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 May 2017 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Implantation of the XPro System
| Arm | Type | Receives |
|---|---|---|
| XPro System | Experimental | Device: XPro SystemImplantation of XPro System during percutaneous vascular closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XPro SystemImplantation of the XPro System | Device | XPro System |
Primary outcome
Time to Hemostasis
Time frame: 15 minutes
Time to hemostasis absent of any access-site-related adjunctive surgical or endovascular procedures.
Freedom from major VARC-2 events
Time frame: Up to 30 days of procedure
Freedom from major VARC-2 events within 30 days of the procedure.
3 secondary outcomes
Freedom from minor VARC-2 events
Time frame: Up to 30 days of procedure
Successful hemostasis with the XPro System
Time frame: at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure
Freedom from access-site infection
Time frame: Up to 30 days of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XPro System in people with Percutaneous Closure of Arteriotomy in Common Femoral Artery, run by Medeon Biodesign, Inc. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in New Zealand, Australia, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Hemostasis (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.