Vascular ClosureNCT05335525
Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
An observational study of Vascular Closure and Endovascular Procedure, run by Terumo Europe N.V. at 4 sites in 3 countries.
Trial summary
The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Closure, Endovascular Procedure, Hemostasis
- What is being tested?
- Closure of the femoral arterial puncture site
- Type of treatment
- Medical device
- How many people
- 230 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 30 Sep 2022to May 2023
- Phase
- Observational
- 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
Study population: 230 enrolled subjects undergoing diagnostic or interventional endovascular procedures in which Angio-SealTM VIP VCD is used
Who may be able to join
- Subject is ≥ 18 years old
- Subject is willing and able to complete the follow-up requirements
- Subject has the mental capacity (i.e., does not require the use of a Legally Authorized Representative) to sign the study Informed Consent Form (ICF)
- Patient undergoing diagnostic or interventional endovascular procedure compatible with the use of Angio-SealTM VIP VCD
- Puncture site located at the femoral artery (i.e., between the inguinal ligament and the bifurcation of the superficial femoral and profunda femoris arteries)
- Angio-SealTM VIP VCD deployed as per instruction for use by a trained operator
Who cannot join
- Use of the Angio-SealTM VIP VCD on puncture sites other than the femoral artery
- Repuncture of the femoral artery within 90 days at the same access site
- Lumen diameter of femoral artery < 4 mm
- Patients with clinically significant peripheral vascular disease at the puncture site (luminal narrowing of >40% within 5 mm of the puncture site)
- Puncture site at or distal to the bifurcation of the superficial femoral and profunda femoris artery
- Puncture site proximal to the inguinal ligament
Show all 11Show fewer
- Procedure sheath placed through the superficial femoral artery into the profunda femoris
- Multiple femoral punctures
- Known or suspected posterior femoral wall puncture
- Use of > 8F primary introducer sheaths or devices for an 8Fr Angio-SealTM VIP, or use of a >6Fr primary introducer sheaths or devices for a 6Fr Angio-SealTM VIP
- Any condition that would make use of Angio-SealTM VIP VCD inappropriate (as per IFU and investigators' discretion)
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites, 2 recruiting
- Not yet recruiting
Hôpital Universitaire Henri Mondor
Créteil, 94000
Hicham Kobeiter
- Recruiting
Hôpital Européen Georges-Pompidou (HEGP), Interventional Radiology department
Paris, 75015
Carole Déan, +33 7 66 14 09 69, carole.dean@aphp.fr
Marc Sapoval
Germany1 site, 1 recruiting
- Recruiting
Bonifatius Hospital Lingen, Clinic for Vascular Surgery
Lingen, 49808
Daniela Viehweider, '+49 (05) 91 910 1247, Daniela.Viehweider@hospital-lingen.de
Jörg Teßarek
Netherlands1 site, 1 recruiting
- Recruiting
VieCuri Medisch Centrum
Venlo, 5912
Coby Van De Bool, 077 320 6755, cvdbool@viecuri.nl
Evelien R Creemers, ecreemers@viecuri.nl
About this study
Official title: Post-market Clinical Investigation of the Angio-Seal™ VIP VCD: A Prospective, Multi-center Observational Study (ANGIO-SEAL CLOSE)
The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.
Read the detailed description
The proposed Post-Market Clinical Follow-up study is a prospective, multi-Center, observational study, aiming to further demonstrate the safety and effectiveness of the Angio-SealTM VIP VCD in achieving hemostasis of femoral artery access site in real-world subjects undergoing percutaneous endovascular procedures. 230 patients will be enrolled at up to 6 sites in Europe. Follow-ups are scheduled at 30 days (+7 days) by hospital visit or telephone call.
The sponsor shall provide training and the necessary guidelines to assist each investigation site on the data collection in the eCRF. Each site is responsible to report the available data requested by the CIP. In order to ensure data quality, validation \& consistency, edit checks will be designed during database development. Data Management team and the study monitors will be responsible to review the data and raise queries in the eCRF. Data cleaning will be done in regular intervals specified in DMP. The final clean standardised datasets will be available prior to database lock for data analysis. An audit trail logging all data entered and edited is available within the EDC system. All source documents are maintained in the hospital files ready for inspection by the Sponsor and regulatory authorities upon request. The Sponsor will inform the investigator of the time period for retaining these records as per applicable regulatory requirements.
The study will be monitored at all stages of its development by study monitors appointed by the sponsor. Study monitors are designated as Sponsor representatives and are assigned to oversee the conduct and progress of the study at each site in accordance with the Monitoring Plan established for this clinical investigation.
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Peripheral Vascular Disease, Femoral Artery
- Being tested
- Closure of the femoral arterial puncture site
- Keywords
- Peripheral Intervention, CFA arteriotomy closure, Common Femoral Artery Access Site, Vascular Closude Device (VCD)
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of the femoral arterial puncture siteDevice
Patient will undergo a diagnostic or interventional endovascular procedure, compatible with the use of Angio-Seal™ VIP VCD.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Successful puncture site haemostasis
Cessation of arterial bleeding (excluding oozing) achieved in the interventional lab in subjects not requiring adjunctive intervention at the access site, including manual compression.
Measured: 6 hours post-procedure
Safety: freedom from major complications of the access site limb
Major complications attributable to Angio-Seal TM VIP VCD are defined as:
- Access site-related bleeding (BARC type 2, 3 or 5, following Angio-SealTM VIP VCD deployment, as per Bleeding Academic Research Consortium (BARC) classification)
- Femoral puncture site haematoma >6
- Pseudoaneurysms requiring intervention
- Femoral access site arteriovenous fistulas
- Access site infection requiring hospitalization
- Embolism (due to Anchor fracture)
- Thrombosis at puncture site (due to collagen disposition into the artery)
- Allergic Reaction to Angio-SealTM VIP components
- Foreign body reaction
- Inflammation and Edema
Measured: 6 hours post-procedure
Secondary outcomes (6)
Freedom from any minor complications at the target limb access site
Minor complications are defined as:
- Femoral puncture site Hematoma <6cm
- Access site Infection not requiring hospitalization
- Pseudoaneurysm not requiring intervention
- Vasovagal response
Measured: 6 hours post-procedure
Freedom from any major and minor complications at the target limb access site
Measured: 30 days post-procedure
Time to hemostasis (TTH)
TTH is defined as time from completion of device deployment up to first observed arterial bleeding cessation (excluding oozing at access site) in subjects not requiring adjunctive intervention in the interventional lab
Measured: up to 1 day
Time to ambulation (TTA)
TTA is defined as the time from device deployment up to the moment when the patient is able to ambulate
Measured: up to 30 days
Quality of Life assessment (EQ-5D)
Measured: 30 days post-procedure
Angio-SealTM VCD usability
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start30 Sep 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ClosureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Terumo Medical Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335525
- Sponsor's protocol ID
- T139E4
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2022
- Last updated
- 20 Apr 2023
- 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Investigation of the Angio-Seal™ VIP VCD: A Prospective, Multi-center Observational Study (ANGIO-SEAL CLOSE)
- ClinicalTrials.gov ID
- NCT05335525
- Acronym / sponsor ID
- T139E4
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Peripheral Vascular Disease, Femoral Artery
- Keywords
- Peripheral Intervention, CFA arteriotomy closure, Common Femoral Artery Access Site, Vascular Closude Device (VCD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Collaborators
- Terumo Medical Corporation
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 19 Apr 2022 (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.
The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.
Detailed description
The proposed Post-Market Clinical Follow-up study is a prospective, multi-Center, observational study, aiming to further demonstrate the safety and effectiveness of the Angio-SealTM VIP VCD in achieving hemostasis of femoral artery access site in real-world subjects undergoing percutaneous endovascular procedures. 230 patients will be enrolled at up to 6 sites in Europe. Follow-ups are scheduled at 30 days (+7 days) by hospital visit or telephone call.
The sponsor shall provide training and the necessary guidelines to assist each investigation site on the data collection in the eCRF. Each site is responsible to report the available data requested by the CIP. In order to ensure data quality, validation \& consistency, edit checks will be designed during database development. Data Management team and the study monitors will be responsible to review the data and raise queries in the eCRF. Data cleaning will be done in regular intervals specified in DMP. The final clean standardised datasets will be available prior to database lock for data analysis. An audit trail logging all data entered and edited is available within the EDC system. All source documents are maintained in the hospital files ready for inspection by the Sponsor and regulatory authorities upon request. The Sponsor will inform the investigator of the time period for retaining these records as per applicable regulatory requirements.
The study will be monitored at all stages of its development by study monitors appointed by the sponsor. Study monitors are designated as Sponsor representatives and are assigned to oversee the conduct and progress of the study at each site in accordance with the Monitoring Plan established for this clinical investigation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 230 enrolled subjects undergoing diagnostic or interventional endovascular procedures in which Angio-SealTM VIP VCD is used
Key inclusion criteria (6 listed)
- Subject is ≥ 18 years old
- Subject is willing and able to complete the follow-up requirements
- Subject has the mental capacity (i.e., does not require the use of a Legally Authorized Representative) to sign the study Informed Consent Form (ICF)
- Patient undergoing diagnostic or interventional endovascular procedure compatible with the use of Angio-SealTM VIP VCD
- Puncture site located at the femoral artery (i.e., between the inguinal ligament and the bifurcation of the superficial femoral and profunda femoris arteries)
Key exclusion criteria (11 listed)
- Use of the Angio-SealTM VIP VCD on puncture sites other than the femoral artery
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 |
|---|---|---|
| Closure of the femoral arterial puncture sitePatient will undergo a diagnostic or interventional endovascular procedure, compatible with the use of Angio-Seal™ VIP VCD. | Device | – |
Primary outcome
Effectiveness: Successful puncture site haemostasis
Time frame: 6 hours post-procedure
Cessation of arterial bleeding (excluding oozing) achieved in the interventional lab in subjects not requiring adjunctive intervention at the access site, including manual compression.
Safety: freedom from major complications of the access site limb
Time frame: 6 hours post-procedure
Major complications attributable to Angio-Seal TM VIP VCD are defined as: * Access site-related bleeding (BARC type 2, 3 or 5, following Angio-SealTM VIP VCD deployment, as per Bleeding Academic Research Consortium (BARC) classification) * Femoral puncture site haematoma >6 * Pseudoaneurysms requiring intervention * Femoral access site arteriovenous fistulas * Access site infection requiring hospitalization * Embolism (due to Anchor fracture) * Thrombosis at puncture site (due to collagen disposition into the artery) * Allergic Reaction to Angio-SealTM VIP components * Foreign body reaction * Inflammation and Edema
6 secondary outcomes
Freedom from any minor complications at the target limb access site
Time frame: 6 hours post-procedure
Freedom from any major and minor complications at the target limb access site
Time frame: 30 days post-procedure
Time to hemostasis (TTH)
Time frame: up to 1 day
Time to ambulation (TTA)
Time frame: up to 30 days
Quality of Life assessment (EQ-5D)
Time frame: 30 days post-procedure
Angio-SealTM VCD usability
Time frame: up to 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Closure and Endovascular Procedure, run by Terumo Europe N.V. at 4 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evelyne Vicca (+32 16 381284, evelyne.vicca@terumo-europe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: Successful puncture site haemostasis (time frame: 6 hours post-procedure). 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 Apr 2023.