Peripheral Arterial DiseaseNCT03730571
The AbsorbaSeal Vascular Closure Device Trial
A study testing AbsorbaSeal 6Fr Vascular Closure Device in people with Peripheral Arterial Disease, run by ID3 Medical at 3 sites in Belgium.
Trial summary
This study investigates the efficacy and safety of the AbsorbaSeal 6Fr 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 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- AbsorbaSeal 6Fr Vascular Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesBelgium
- Study dates
- 16 Aug 2017to 11 Apr 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is between 18 and 85 years of age
- Male and Female
- Patient/legal representative provides written informed consent
- Patient is scheduled for a coronary or 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 6 french arterial puncture located in the common femoral artery
Show all 9Show fewer
- Target vessel has a lumen diameter ≥ 5 mm
- Patient is willing and able to complete follow-up
- Catheterization procedure is planned and elective
Who cannot join
- Prior target artery closure with any closure device or closure with manual compression ≤ 30 days prior to the cardiac or peripheral catheterization procedure
- Patients with a history of significant bleeding or with any known or documented bleeding disorders, such as Thrombocytopenia (with < 100,000 platelet count), Von Willebrand's 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 cardiac or peripheral catheterization procedure
- Patient is ineligible for in-lab catheterization lab introducer sheath removal
- Concurrent participation in another investigational device or drug trial
- Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the cardiac or peripheral catheterization procedure
Show all 10Show fewer
- Evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm 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
- The targeted femoral artery is tortuous or requires a sheath length > 10 cm
- Patient is pregnant or breastfeeding
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
O.L.V. Hospital
Aalst, 9300
Imelda Hospital
Bonheiden, 2820
A.Z. Sint-Blasius
Dendermonde, 9200
About this study
Official title: Prospective, Multi-center, Non-Randomized Controlled Trial of Vascular Closure Using the AbsorbaSeal 6 French Vascular Closure Device
This study investigates the efficacy and safety of the AbsorbaSeal 6Fr 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 AbsorbaSeal 6Fr VCD. Enrollment into this study will include anatomically eligible patients requiring diagnostic and interventional 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 faster, safer, and more secure hemostasis following these outpatient procedures. CyndRx believes an improved VCD will lead to more widespread use and ultimately improve patient outcomes. The AbsorbaSeal Vascular Closure Device (ABS-6) has been developed to meet this need. The ease of use and automatic deployment of the device will eliminate the learning curve associated with the use of VCDs. The active closure system used in the ABS-6 ensures a secure closure with every deployment. 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.
The First In Man (FIM) trial demonstrated the safety and efficacy of the ABS-6 system in humans (N=20). To further evaluate the safety and efficacy, up to 50 patients will be enrolled in the CP002CE-study.
The primary objective of this study is to assess the safety and effectiveness of the AbsorbaSeal 6Fr VCD. 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
- AbsorbaSeal 6Fr Vascular Closure Device
- 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.
AbsorbaSeal 6Fr Vascular Closure DeviceDevice
Patients whose access site will be closed with the AbsorbaSeal 6Fr Vascular Closure Device
| Study group | Role | What they receive |
|---|---|---|
| AbsorbaSeal 6Fr Vascular Closure Device | Experimental | Patients whose access site will be closed with the AbsorbaSeal 6Fr Vascular Closure Device Receives: Device: AbsorbaSeal 6Fr Vascular Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
Composite of (1) procedural technical success (successful vascular access and ABS-6 delivery, deployment and catheter removal), (2) absence of vascular complications (arteriovenous fistula, femoral neuropathy, hematoma >6cm, hemorrhage, infection, lymphocele, thrombosis/occlusion/distal emboli/stenosis, vascular injury) (3) absence of major adverse events (all-cause death, cardiac morbidity, neurological complications, renal failure, respiratory complications, secondary intervention for groin complications)
Measured: 30 days post-index procedure
Secondary outcomes (10)
Number of Adverse events
All adverse events will be monitored. A serious adverse event is defined as an event that results in death, is life threatening, requires inpatient hospitalization or that prolongs hospitalization, results in persistent or significant disability/incapacity
Measured: 30 days post-index procedure
Volume of contrast media used during index procedure
Volume of contrast media used (ml)
Measured: Intraoperative
Fluoroscopy time during index procedure
Fluoroscopy time (min)
Measured: Intraoperative
Estimated blood loss during index procedure
Estimated blood loss (ml)
Measured: Intraoperative
Time to hemostasis after index procedure
Time to hemostasis (min)
Measured: Intraoperative
Total procedure time of index procedure
Total procedure time (min)
Measured: Intraoperative
Anesthesia time of index procedure
Anesthesia time (min)
Measured: Intraoperative
Total time of initial hospitalization stay
Total time of initial hospitalization stay (h:min)
Measured: Up to 1 month post-index procedure
Analgesic usage after index-procedure
Arterial access site pain-related analgesic usage after index procedure until patient discharge
Measured: 1-day post-index procedure
Pain Evaluation
Self-reported groin pain scale (0 (no pain) - 10 (excessive pain))
Measured: 1-day post-index procedure and 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start16 Aug 2017
- Primary completion11 Apr 2019
- Study completion11 Apr 2019
Why it stopped: Insufficient closure
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
- 9 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, ID3 Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730571
- Sponsor's protocol ID
- CP002CE
- Status last verified
- Sep 2021
- First submitted
- 28 Sep 2018
- Last updated
- 8 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 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Non-Randomized Controlled Trial of Vascular Closure Using the AbsorbaSeal 6 French Vascular Closure Device
- ClinicalTrials.gov ID
- NCT03730571
- Acronym / sponsor ID
- CP002CE
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient closure
- Enrolment
- 9 participants (actual)
- Lead sponsor
- ID3 MedicalUniversity, hospital or other
- Collaborators
- CyndRx, LLC
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 5 Nov 2018 (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 6Fr 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 AbsorbaSeal 6Fr VCD. Enrollment into this study will include anatomically eligible patients requiring diagnostic and interventional 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 faster, safer, and more secure hemostasis following these outpatient procedures. CyndRx believes an improved VCD will lead to more widespread use and ultimately improve patient outcomes. The AbsorbaSeal Vascular Closure Device (ABS-6) has been developed to meet this need. The ease of use and automatic deployment of the device will eliminate the learning curve associated with the use of VCDs. The active closure system used in the ABS-6 ensures a secure closure with every deployment. 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.
The First In Man (FIM) trial demonstrated the safety and efficacy of the ABS-6 system in humans (N=20). To further evaluate the safety and efficacy, up to 50 patients will be enrolled in the CP002CE-study.
The primary objective of this study is to assess the safety and effectiveness of the AbsorbaSeal 6Fr VCD. 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 |
|---|---|---|
| AbsorbaSeal 6Fr Vascular Closure Device | Experimental | Device: AbsorbaSeal 6Fr Vascular Closure DevicePatients whose access site will be closed with the AbsorbaSeal 6Fr Vascular Closure Device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is between 18 and 85 years of age
- Male and Female
- Patient/legal representative provides written informed consent
- Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure
- Patient is able to undergo emergent vascular surgery if a complication related to the VCD necessitates such surgery
Key exclusion criteria (10 listed)
- Prior target artery closure with any closure device or closure with manual compression ≤ 30 days prior to the cardiac or peripheral catheterization procedure
- Patients with a history of significant bleeding or with any known or documented bleeding disorders, such as Thrombocytopenia (with < 100,000 platelet count), Von Willebrand's 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 cardiac or peripheral catheterization procedure
- Patient is ineligible for in-lab catheterization lab introducer sheath removal
- Concurrent participation in another investigational device or drug trial
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 |
|---|---|---|
| AbsorbaSeal 6Fr Vascular Closure DevicePatients whose access site will be closed with the AbsorbaSeal 6Fr Vascular Closure Device | Device | AbsorbaSeal 6Fr Vascular Closure Device |
Primary outcome
Treatment success
Time frame: 30 days post-index procedure
Composite of (1) procedural technical success (successful vascular access and ABS-6 delivery, deployment and catheter removal), (2) absence of vascular complications (arteriovenous fistula, femoral neuropathy, hematoma >6cm, hemorrhage, infection, lymphocele, thrombosis/occlusion/distal emboli/stenosis, vascular injury) (3) absence of major adverse events (all-cause death, cardiac morbidity, neurological complications, renal failure, respiratory complications, secondary intervention for groin complications)
10 secondary outcomes
Number of Adverse events
Time frame: 30 days post-index procedure
Volume of contrast media used during index procedure
Time frame: Intraoperative
Fluoroscopy time during index procedure
Time frame: Intraoperative
Estimated blood loss during index procedure
Time frame: Intraoperative
Time to hemostasis after index procedure
Time frame: Intraoperative
Total procedure time of index procedure
Time frame: Intraoperative
Anesthesia time of index procedure
Time frame: Intraoperative
Total time of initial hospitalization stay
Time frame: Up to 1 month post-index procedure
Analgesic usage after index-procedure
Time frame: 1-day post-index procedure
Pain Evaluation
Time frame: 1-day post-index procedure and 1 month follow-up
Results and safety
The study was stopped early (reason given: Insufficient closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
Related trials for Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
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
ID3 Medical
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AbsorbaSeal 6Fr Vascular Closure Device in people with Peripheral Arterial Disease, run by ID3 Medical at 3 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 9 inclusion and 10 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: stopped early, as of the sponsor's last update on 8 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 3 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 was stopped early (reason given: Insufficient closure). Results are not available in the source record.
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?
Treatment success (time frame: 30 days post-index procedure). 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 8 Sep 2021.