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The AbsorbaSeal Vascular Closure Device Trial

Primary Purpose

Peripheral Arterial Disease

Status

Terminated

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

AbsorbaSeal 6Fr Vascular Closure Device

About this trial

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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Target vessel has a lumen diameter ≥ 5 mm
Patient is willing and able to complete follow-up
Catheterization procedure is planned and elective

Exclusion Criteria:

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
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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AbsorbaSeal 6Fr Vascular Closure Device

Arm Description

Patients whose access site will be closed with the AbsorbaSeal 6Fr Vascular Closure Device

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Volume of contrast media used during index procedure

Volume of contrast media used (ml)

Fluoroscopy time during index procedure

Fluoroscopy time (min)

Estimated blood loss during index procedure

Estimated blood loss (ml)

Time to hemostasis after index procedure

Time to hemostasis (min)

Total procedure time of index procedure

Total procedure time (min)

Anesthesia time of index procedure

Anesthesia time (min)

Total time of initial hospitalization stay

Total time of initial hospitalization stay (h:min)

Analgesic usage after index-procedure

Arterial access site pain-related analgesic usage after index procedure until patient discharge

Pain Evaluation

Self-reported groin pain scale (0 (no pain) - 10 (excessive pain))

Full Information

NCT ID

NCT03730571

First Posted

September 28, 2018

Last Updated

September 7, 2021

Sponsor

ID3 Medical

Collaborators

CyndRx, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03730571

Brief Title

The AbsorbaSeal Vascular Closure Device Trial

Official Title

Prospective, Multi-center, Non-Randomized Controlled Trial of Vascular Closure Using the AbsorbaSeal 6 French Vascular Closure Device

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Terminated

Why Stopped

Insufficient closure

Study Start Date

August 16, 2017 (Actual)

Primary Completion Date

April 11, 2019 (Actual)

Study Completion Date

April 11, 2019 (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 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.

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

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AbsorbaSeal 6Fr Vascular Closure Device

Arm Type

Experimental

Arm Description

Patients whose access site will be closed with the AbsorbaSeal 6Fr Vascular Closure Device

Intervention Type

Device

Intervention Name(s)

AbsorbaSeal 6Fr Vascular Closure Device

Intervention Description

Patients whose access site will be closed with the AbsorbaSeal 6Fr Vascular Closure Device

Primary Outcome Measure Information:

Title

Treatment success

Description

Time Frame

30 days post-index procedure

Secondary Outcome Measure Information:

Title

Number of Adverse events

Description

Time Frame

30 days post-index procedure

Title

Volume of contrast media used during index procedure

Description

Volume of contrast media used (ml)

Time Frame

Intraoperative

Title

Fluoroscopy time during index procedure

Description

Fluoroscopy time (min)

Time Frame

Intraoperative

Title

Estimated blood loss during index procedure

Description

Estimated blood loss (ml)

Time Frame

Intraoperative

Title

Time to hemostasis after index procedure

Description

Time to hemostasis (min)

Time Frame

Intraoperative

Title

Total procedure time of index procedure

Description

Total procedure time (min)

Time Frame

Intraoperative

Title

Anesthesia time of index procedure

Description

Anesthesia time (min)

Time Frame

Intraoperative

Title

Total time of initial hospitalization stay

Description

Total time of initial hospitalization stay (h:min)

Time Frame

Up to 1 month post-index procedure

Title

Analgesic usage after index-procedure

Description

Arterial access site pain-related analgesic usage after index procedure until patient discharge

Time Frame

1-day post-index procedure

Title

Pain Evaluation

Description

Self-reported groin pain scale (0 (no pain) - 10 (excessive pain))

Time Frame

1-day post-index procedure and 1 month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Target vessel has a lumen diameter ≥ 5 mm Patient is willing and able to complete follow-up Catheterization procedure is planned and elective Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Koen Deloose, MD

Organizational Affiliation

ID3 Medical

Official's Role

Principal Investigator

Facility Information:

Facility Name

O.L.V. Hospital

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Imelda Hospital

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

A.Z. Sint-Blasius

City

Dendermonde

ZIP/Postal Code

9200

Country

Belgium

12. IPD Sharing Statement

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The AbsorbaSeal Vascular Closure Device Trial

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