Peripheral Arterial Disease
Conditions
Brief 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. 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.
Interventions
DEVICEABS 5.6.7
Patients whose access site will be closed with the ABS 5.6.7
Sponsors
ID3 Medical
CyndRx, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of major complications | 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) | Intraoperative | TTH is defined as elapsed time between ABS 5.6.7 removal and first observed hemostasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of minor complications | Post-procedure follow up 30 ± 7 days | 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 |
| Device success | Within 5 minutes following ABS 5.6.7 deployment | 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. |
| Procedure success | Post-procedure follow up 30 ± 7 days | Procedure Success defined as attainment of final arterial hemostasis using any method. |
Countries
Belgium
Outcome results
None listed