An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Stent for Iliac Lesions Via a Trans-radial Approach

Sponsor

Klinikum Arnsberg (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05372952

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This feasibility study with a 30 day follow up period will assess the safety and feasibility of the Dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Device: Dynetic-35 Peripheral Balloon-Expandable Stent System

Study Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Cobalt Chromium Balloon-expandable Stent for the Treatment of Atherosclerotic Iliac Lesions Via a Trans-radial Approach - Bionetic-TRA

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Outcome Measures

Primary Outcome Measures

Access site complications [1 hour post procedure]
bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion
Stroke [30 days]
Death [30 days]
Transradial technical success [Immediately after stent placement via radial access]
Successful delivery of the Dynetic-35 stent at the lesion site with residual stenosis of ≤ 30%
Number of patients converting to femoral artery access [1 hour post procedure]
Transradial access feasibility is assessed as number of patients in whom access is converted to femoral artery access due to failure to access the lesion via the radial artery

Secondary Outcome Measures

Length of hospital stay [hours] [up to 30 days]
Procedure time [min] [Intraoperative]
Procedure cost [1 hour post procedure]
Number and details of auxiliary devices and medication used
Time to ambulation [up to 30 days]
Time between patient left the cath lab/operating theatre, and patient was able to walk 100 meters and the access site remained stable
Patient satisfaction regarding access site [24 hours post procedure]
Patient questionnaire assessing 8 questions (anxiety about the procedure, overall pain, back pain, difficulties in toiletting, walking, daily movement, selfcare and using the dominant hand) on a numeric rating scale (NRS, 0-10, 0 = none, 10 most severe).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is ≥ 18 years
Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
Subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements
Subjects have a target lesion(s) with ≥ 70% stenosis (visual estimate) located in the iliac arteries
Target lesion is a de novo, restenotic or occluded lesion
Reference lumen (vessel) diameter between 5mm and 10 mm
The target lesion can be successfully crossed with a guide wire
Patient is eligible for transradial access
Subject has symptomatic iliac artery disease defined as Rutherford category 2 or higher

Exclusion Criteria:

Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study.
Subject is with a current medical condition with a life expectancy of less than one year.
Pre-existing target iliac artery aneurysm or perforation or dissection
Any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol
Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment
The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet
Subjects with small diameter upper extremity arteries that posed a contraindication to the use of 6F sheath
Severe stenosis or calcification of upper extremity arteries
Patient height precluding transradial access with a 170 cm long catheter shaft
Patient with a history of aortic arch atheroembolism
Infrainguinal outflow lesions that need to be treated during the same index procedure
Patients with negative bilateral Allen or barbeau tests (Note: vascular access should be done via the left hand where possible)
Subject has IFU listed contraindication(s)
Subject has in-stent restenosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vascular center of Klinikum Hochsauerland GmbH	Arnsberg		Germany	59759

Sponsors and Collaborators

Klinikum Arnsberg

Investigators

Principal Investigator: Michael H Lichtenberg, MD, Klinikum Hochsauerland GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Klinikum Arnsberg

ClinicalTrials.gov Identifier:

NCT05372952

Other Study ID Numbers:

ASL202201

First Posted:

May 13, 2022

Last Update Posted:

Jul 20, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Klinikum Arnsberg

transradial access,

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study Results

No Results Posted as of Jul 20, 2022