Peripheral Arterial DiseaseNCT04635501
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
A study testing ABS 5.6.7 in people with Peripheral Arterial Disease, run by ID3 Medical at 2 sites in Belgium.
Trial summary
This study investigates the efficacy and safety of the AbsorbaSeal (ABS 5.6.7.) Vascular Closure device (VCD) for the closure of access site of patients requiring percutaneous diagnostic or interventional procedures. An expected total of 50 patients will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- ABS 5.6.7
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesBelgium
- Study dates
- 23 Sep 2020to 7 Jun 2021
- 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, male or female, minimum age of 18
- Patient provides written Informed Consent
- Patient is scheduled for a peripheral diagnostic or interventional procedure
- Patient is able to undergo emergent vascular surgery if a complication related to the VCD necessitates such surgery
- Patient has a 6French arterial puncture located in the common femoral artery (CFA)
- Target vessel has a lumen diameter > 5 mm
Show all 31Show fewer
- Patient is willing and able to comply with all Study visits and procedures and complete follow-up visit
- Catheterization procedure is planned and elective
- Pre-Procedure Exclusion Criteria:
- Prior target artery closure with any closure device or closure with manual compression ≤ 30 days prior to the peripheral catheterization procedure
- History of significant bleeding or with any known or documented bleeding disorders, such as thrombocytopenia (with < 100,000 platelet count), von Willebrand disease, anemia (Hgb < 10 g/Dl, Hct < 30%), thrombasthenia, decreased fibrinogen (< 200 mg/Dl), and Factor V deficiency
- Acute ST-elevation myocardial infarction ≤ 48 hours prior to the peripheral catheterization procedure
- Ineligible for introducer sheath removal
- Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the peripheral catheterization procedure
- Evidence of a preexisting hematoma, arteriovenous fistula, or pseudo-aneurysm at the access site prior to start of femoral artery closure procedure
- Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery
- Targeted femoral artery is tortuous or requires a sheath length > 10 cm
- Pregnant or lactating
- Mean body mass index (BMI) > 35 kg/m²
- Existing nerve damage in ipsilateral limb
- Fibrotic, heavily calcified femoral artery within 10mm of the entry point
- Non-palpable pulses in affected access limb
- Intra-Procedure Exclusion Criteria:
- Difficult insertion of procedural sheath, needle stick problems at the onset of the peripheral procedure or difficult insertion of ABS 5.6.7
- Procedural sheath placement either through superficial femoral artery or into the profunda femoris artery or placement at or distal to bifurcation of the superficial femoral artery and the profunda femoris artery
- Common femoral artery (CFA) puncture site located above the lowest sweep of the inferior epigastric artery; referred to as a "high stick"
- Common femoral artery (CFA) access puncture site located on the front wall that continues through the back wall of the targeted vessel; referred to as a "back wall stick"
- Common femoral artery (CFA) access puncture site with multiple punctures of the CFA in an attempt to gain access to the targeted vessel known as "multiple sticks"
- Common femoral artery (CFA) access puncture located in the side wall region of the targeted access vessel; referred to as a "side wall stick"
- Interventional procedures with multiple exchanges during the procedure that cause elongation and trauma to the vessel compromising the tight seal between the vessel and the sheath
- Hematoma developing during the course of the percutaneous procedure
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prospective, Multicenter, Single Arm, Pre-CE Marked Study of the AbsorbaSeal (ABS 5.6.7) Vascular Closure Device
This study investigates the efficacy and safety of the AbsorbaSeal (ABS 5.6.7.) Vascular Closure device (VCD) for the closure of access site of patients requiring percutaneous diagnostic or interventional procedures. An expected total of 50 patients will be enrolled in this study. A total of 12 patients (4 patients per site) will be treated as roll-in phase, prior to enrollment of the first patient. The primary objective of this study is to assess the safety and effectiveness of the ABS 5.6.7. VCD in sealing the femoral arterial access site following diagnostic or interventional peripheral or coronary procedures. Following physician training, patients will be enrolled. Efficacy and safety analyses will be based on these patients. Patients will be followed procedurally to discharge, at one month, (follow-up commitment). Secondary objectives are to further characterize adverse events (serious and non-serious), clinical utility measures and health-related quality of life.
Read the detailed description
With the increased number of percutaneous interventions being performed in outpatient settings, there is a growing need to obtain safer, faster, and more secure hemostasis following these procedures. Due to its automatic deployment feature and simplicity in operation. AbsorbaSeal (ABS 5.6.7) will lead to more widespread use and improve patient outcomes. The active closure system used in the ABS 5.6.7 ensures a secure closure. The composition of the seal used is completely bio-absorbable and does not require the use of adjunct materials (i.e. collagen, sutures, staples, etc.) needed in many of the devices currently available.
Extensive laboratory testing, acute animal labs and deployment in chronic animal studies were performed with ABS 6. After a few device modification to create the improved ABS 5.6.7, only minimal confirmatory testing was performed with the current, modified ABS 5.6.7. The extensive test results on the previous device iterations are used to complete the confirmatory testing of the ABS 5.6.7 design.
The First in Man (FIM) trial (CP001) supports the initial safety and effectiveness of ABS 5.6.7 in humans (n=20) and was completed prior to application for a pivotal Investigational Device Exemption (IDE) Study in the United States and a CE Mark Study approval (CP004CE) in the European Union.
The primary objective of this study is to assess the safety and effectiveness of the ABS 5.6.7. Enrollment into this study will include anatomically eligible patients requiring diagnostic and interventional procedures. Patients will be followed procedurally to discharge, at one month, (follow-up commitment). Secondary objectives are to further characterize adverse events (serious and non-serious), clinical utility measures, and health-related quality of life.
- Conditions
- Peripheral Arterial Disease
- Being tested
- ABS 5.6.7
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABS 5.6.7Device
Patients whose access site will be closed with the ABS 5.6.7
| Study group | Role | What they receive |
|---|---|---|
| ABS 5.6.7 | Experimental | Patients whose access site will be closed with the AbsorbaSeal 5.6.7 Vascular Closure Device Receives: Device: ABS 5.6.7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major complications
Composite of (1) closure-related bleeding requiring transfusion, (2) closure related vascular injury requiring repair surgery, (3) new ipsilateral lower extremity ischemia causing a threat to viability of limb requiring surgical or endovascular intervention, (4) closure-related infection requiring intravenous antibiotics and/or extended hospitalization, (5) new onset closure-related neuropathy in the ipsilateral lower extremity requiring surgical repair, and (6) permanent closure-related nerve damage.
Measured: Post-procedure follow up 30 ± 7 days
Time to hemostasis (TTH) after index procedure (min)
TTH is defined as elapsed time between ABS 5.6.7 removal and first observed hemostasis
Measured: Intraoperative
Secondary outcomes (3)
Rate of minor complications
Composite of (1) closure-related bleeding requiring > 30 min. of continual manual compression to achieve initial arterial hemostasis, (2) late closure-related arterial bleeding (following hospital discharge), (3) closure-related hematoma > 6 cm, (4) Ipsilateral lower extremity arterial emboli, (5) ipsilateral deep vein thrombosis, (6) closure-related vessel laceration, (7) access site wound dehiscence, (8) localized access site infection treated with intramuscular or oral antibiotics, (9) closure related arteriovenous fistula not requiring treatment, (10) closure related pseudo-aneurysm requiring thrombin injection or fibrin adhesive injection, (11) closure related pseudo-aneurysm not requiring treatment, and (12) new onset of transient access site closure related neuropathy in the ipsilateral lower extremity that is transient (> 24 hrs. and < 30 days) and does not require surgical repair
Measured: Post-procedure follow up 30 ± 7 days
Device success
Device Success defined as the ability to deploy the implant and achieve arterial hemostasis with ABS 5.6.7 alone or with post hemostasis adjunctive manual compression for 5 minutes or less.
Measured: Within 5 minutes following ABS 5.6.7 deployment
Procedure success
Procedure Success defined as attainment of final arterial hemostasis using any method.
Measured: Post-procedure follow up 30 ± 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start23 Sep 2020
- Primary completion5 May 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- ID3 Medical
- Sponsor type
- University, hospital or other
- Collaborators
- CyndRx, LLC
- Responsible party
- Sponsor
- Investigators
- Koen Deloose, MD, Principal investigator, AZ Sint Blasius
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635501
- Sponsor's protocol ID
- CP004CE
- Status last verified
- Sep 2021
- First submitted
- 13 Nov 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single Arm, Pre-CE Marked Study of the AbsorbaSeal (ABS 5.6.7) Vascular Closure Device
- ClinicalTrials.gov ID
- NCT04635501
- Acronym / sponsor ID
- CP004CE
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- ID3 MedicalUniversity, hospital or other
- Collaborators
- CyndRx, LLC
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 19 Nov 2020 (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.
This study investigates the efficacy and safety of the AbsorbaSeal (ABS 5.6.7.) Vascular Closure device (VCD) for the closure of access site of patients requiring percutaneous diagnostic or interventional procedures. An expected total of 50 patients will be enrolled in this study. A total of 12 patients (4 patients per site) will be treated as roll-in phase, prior to enrollment of the first patient. The primary objective of this study is to assess the safety and effectiveness of the ABS 5.6.7. VCD in sealing the femoral arterial access site following diagnostic or interventional peripheral or coronary procedures. Following physician training, patients will be enrolled. Efficacy and safety analyses will be based on these patients. Patients will be followed procedurally to discharge, at one month, (follow-up commitment). Secondary objectives are to further characterize adverse events (serious and non-serious), clinical utility measures and health-related quality of life.
Detailed description
With the increased number of percutaneous interventions being performed in outpatient settings, there is a growing need to obtain safer, faster, and more secure hemostasis following these procedures. Due to its automatic deployment feature and simplicity in operation. AbsorbaSeal (ABS 5.6.7) will lead to more widespread use and improve patient outcomes. The active closure system used in the ABS 5.6.7 ensures a secure closure. The composition of the seal used is completely bio-absorbable and does not require the use of adjunct materials (i.e. collagen, sutures, staples, etc.) needed in many of the devices currently available.
Extensive laboratory testing, acute animal labs and deployment in chronic animal studies were performed with ABS 6. After a few device modification to create the improved ABS 5.6.7, only minimal confirmatory testing was performed with the current, modified ABS 5.6.7. The extensive test results on the previous device iterations are used to complete the confirmatory testing of the ABS 5.6.7 design.
The First in Man (FIM) trial (CP001) supports the initial safety and effectiveness of ABS 5.6.7 in humans (n=20) and was completed prior to application for a pivotal Investigational Device Exemption (IDE) Study in the United States and a CE Mark Study approval (CP004CE) in the European Union.
The primary objective of this study is to assess the safety and effectiveness of the ABS 5.6.7. Enrollment into this study will include anatomically eligible patients requiring diagnostic and interventional procedures. Patients will be followed procedurally to discharge, at one month, (follow-up commitment). Secondary objectives are to further characterize adverse events (serious and non-serious), clinical utility measures, and health-related quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABS 5.6.7 | Experimental | Device: ABS 5.6.7Patients whose access site will be closed with the AbsorbaSeal 5.6.7 Vascular Closure Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Patient, male or female, minimum age of 18
- Patient provides written Informed Consent
- Patient is scheduled for a peripheral diagnostic or interventional procedure
- Patient is able to undergo emergent vascular surgery if a complication related to the VCD necessitates such surgery
- Patient has a 6French arterial puncture located in the common femoral artery (CFA)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ABS 5.6.7Patients whose access site will be closed with the ABS 5.6.7 | Device | ABS 5.6.7 |
Primary outcome
Rate of major complications
Time frame: Post-procedure follow up 30 ± 7 days
Composite of (1) closure-related bleeding requiring transfusion, (2) closure related vascular injury requiring repair surgery, (3) new ipsilateral lower extremity ischemia causing a threat to viability of limb requiring surgical or endovascular intervention, (4) closure-related infection requiring intravenous antibiotics and/or extended hospitalization, (5) new onset closure-related neuropathy in the ipsilateral lower extremity requiring surgical repair, and (6) permanent closure-related nerve damage.
Time to hemostasis (TTH) after index procedure (min)
Time frame: Intraoperative
TTH is defined as elapsed time between ABS 5.6.7 removal and first observed hemostasis
3 secondary outcomes
Rate of minor complications
Time frame: Post-procedure follow up 30 ± 7 days
Device success
Time frame: Within 5 minutes following ABS 5.6.7 deployment
Procedure success
Time frame: Post-procedure follow up 30 ± 7 days
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 5 Sep 2021.
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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.
Koen Deloose, MD principal investigator
AZ Sint Blasius
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABS 5.6.7 in people with Peripheral Arterial Disease, run by ID3 Medical at 2 sites in Belgium.
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 31 inclusion and 0 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Rate of major complications (time frame: Post-procedure follow up 30 ± 7 days). 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 5 Sep 2021.