The AbsorbaSeal Vascular Closure Device Trial

NCT03730571 | Terminated

• 1 other identifier: CP002CE
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days post-index procedure

Secondary Outcomes (10)

• Number of Adverse events

  30 days post-index procedure

• Volume of contrast media used during index procedure

  Intraoperative

• Fluoroscopy time during index procedure

  Intraoperative

• Estimated blood loss during index procedure

  Intraoperative

• Time to hemostasis after index procedure

  Intraoperative

Study Arms (1)

AbsorbaSeal 6Fr Vascular Closure Device

EXPERIMENTAL

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

Device: AbsorbaSeal 6Fr Vascular Closure Device

Interventions

AbsorbaSeal 6Fr Vascular Closure Device DEVICE

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

AbsorbaSeal 6Fr Vascular Closure Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ID3 Medical: lead
• CyndRx, LLC: collaborator

Study Sites (3)

O.L.V. Hospital

Aalst, 9300, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, 9200, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Koen Deloose, MD

  ID3 Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: November 5, 2018
• Study Start: August 16, 2017
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: September 8, 2021

Record last verified: 2021-09

Locations

BE (3)