AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial

ID3 Medical

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Device: ABS 5.6.7

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04635501

CP004CE

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 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