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AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial

NCT04635501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-09-05

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

ABS 5.6.7

Patients whose access site will be closed with the ABS 5.6.7

Sponsors & Collaborators

  • CyndRx, LLC

    collaborator INDUSTRY

  • ID3 Medical

    lead OTHER

Principal Investigators

  • Koen Deloose, MD · AZ Sint Blasius

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2021-05-05
Completion
2021-06-07

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635501 on ClinicalTrials.gov