Clinical trial NCT05812768: Suture-Tight™ First-in-Human Safety and Performance Study
Official title: Suture-Tight™ First-in-Human Safety and Performance Study (CLP-05)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: EVAR
AAA
Anchor
Lead sponsor: Vesteck, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Prince of Wales Hospital, Sydney
First posted: 2023-04-14
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects meeting all inclusion/exclusion criteria and scheduled for an EVAR procedure.
Primary purpose: TREATMENT

Brief summary: Single center, open label, prospective, single-arm, first-in-human (FIH), pre-market clinical study with the objective of validating the safety and performance of the Suture-Tight™ Suture Delivery System in an EVAR procedure.

Detailed description: Single center, study conducted at the Prince of Wales Private Hospital in Randwick, Australia. Up to 6 subjects may be enrolled. 1 to 3 subjects will complete initial enrollment and be followed for 30-days evaluating procedure and device safety. Additional subjects may be enrolled following the safety review to complete the 6-subject study. All subjects will be followed for six (6) months.

Subjects meeting all inclusion and exclusion criteria will be consented to receive an elective endovascular aortic aneurysm repair (EVAR) with graft anchoring utilizing the Suture-Tight device. Procedure and device safety and performance will be evaluated at 1- and 6-months by completing CT scans and KUB x-rays.

Data may be used to support a pivotal study of the investigational device and future global regulatory submissions.

Eligibility criteria: Inclusion Criteria:

* Currently scheduled for an elective endovascular repair of an abdominal aortic aneurysm (AAA) by EVAR with CT scan from within last 4 months. Acceptable AAA parameters include: AAA ≥ 5.0 cm in diameter OR AAA ≥ 4.5 cm in diameter with an increase of ≥ 0.5 cm within the past 6-months or ≥ 1.0 cm over the past 12-months
* Neck diameter, length and angulation that meets labeling requirements for the endograft used
* Successful EVAR graft placement with no evidence of EVAR-associated serious adverse event.

Exclusion Criteria:

* Mycotic or inflammatory AAA
* Prior surgical repair of an AAA
* Renal dialysis or significant chronic renal failure
* Evidence of recent acute coronary disease, thrombotic disease, or cerebral infarct
* Pregnancy

Primary outcomes:
measure: Serious Adverse Events related to the Suture-Tight Suture Delivery System
timeFrame: 30-days
measure: Analysis of the Suture-Tight endoanchor effectiveness
timeFrame: 30-days
Secondary outcomes:
measure: All cause safety events recorded during the study
timeFrame: 6-months
measure: Clinical Performance of the Stent Graft following Suture-Tight implant
timeFrame: 6-months
measure: Clinical Performance of the Suture-Tight following implant
timeFrame: 6-months
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Prince of Wales Private Hospital
state: New South Wales
Study officials:
affiliation: Prince of Wales Private Hospital
name: Ramon Varcoe, MD
role: PRINCIPAL_INVESTIGATOR
References: