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AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial

Primary Purpose

Peripheral Arterial Disease

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

ABS 5.6.7

About this trial

This is an interventional health services research trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

O.L.V. Hospital
A.Z. Sint-Blasius

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABS 5.6.7

Arm Description

Patients whose access site will be closed with the AbsorbaSeal 5.6.7 Vascular Closure Device

Outcomes

Primary Outcome Measures

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.

Time to hemostasis (TTH) after index procedure (min)

TTH is defined as elapsed time between ABS 5.6.7 removal and first observed hemostasis

Secondary Outcome Measures

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

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.

Procedure success

Procedure Success defined as attainment of final arterial hemostasis using any method.

Full Information

NCT ID

NCT04635501

First Posted

November 13, 2020

Last Updated

September 3, 2021

Sponsor

ID3 Medical

Collaborators

CyndRx, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04635501

Brief Title

AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial

Official Title

Prospective, Multicenter, Single Arm, Pre-CE Marked Study of the AbsorbaSeal (ABS 5.6.7) Vascular Closure Device

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

September 23, 2020 (Actual)

Primary Completion Date

May 5, 2021 (Actual)

Study Completion Date

June 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ID3 Medical

Collaborators

CyndRx, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABS 5.6.7

Arm Type

Experimental

Arm Description

Patients whose access site will be closed with the AbsorbaSeal 5.6.7 Vascular Closure Device

Intervention Type

Device

Intervention Name(s)

ABS 5.6.7

Intervention Description

Patients whose access site will be closed with the ABS 5.6.7

Primary Outcome Measure Information:

Title

Rate of major complications

Description

Time Frame

Post-procedure follow up 30 ± 7 days

Title

Time to hemostasis (TTH) after index procedure (min)

Description

TTH is defined as elapsed time between ABS 5.6.7 removal and first observed hemostasis

Time Frame

Intraoperative

Secondary Outcome Measure Information:

Title

Rate of minor complications

Description

Time Frame

Post-procedure follow up 30 ± 7 days

Title

Device success

Description

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.

Time Frame

Within 5 minutes following ABS 5.6.7 deployment

Title

Procedure success

Description

Procedure Success defined as attainment of final arterial hemostasis using any method.

Time Frame

Post-procedure follow up 30 ± 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Koen Deloose, MD

Organizational Affiliation

AZ Sint Blasius

Official's Role

Principal Investigator

Facility Information:

Facility Name

O.L.V. Hospital

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

A.Z. Sint-Blasius

City

Dendermonde

ZIP/Postal Code

9200

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial

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