AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial

NCT04635501 | Completed

• 1 other identifier: CP004CE
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  Post-procedure follow up 30 ± 7 days

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

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

  Intraoperative

Secondary Outcomes (3)

• Rate of minor complications

  Post-procedure follow up 30 ± 7 days

• Device success

  Within 5 minutes following ABS 5.6.7 deployment

• Procedure success

  Post-procedure follow up 30 ± 7 days

Study Arms (1)

ABS 5.6.7

EXPERIMENTAL

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

Device: ABS 5.6.7

Interventions

ABS 5.6.7 DEVICE

Patients whose access site will be closed with the ABS 5.6.7

ABS 5.6.7

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ID3 Medical: lead
• CyndRx, LLC: collaborator

Study Sites (2)

O.L.V. Hospital

Aalst, 9300, 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

  AZ Sint Blasius

  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: November 13, 2020
• First Posted: November 19, 2020
• Study Start: September 23, 2020
• Primary Completion: May 5, 2021
• Study Completion: June 7, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

BE (2)