Clinical trial NCT05372952: An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Stent for Iliac Lesions Via a Trans-radial Approach
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Keywords: transradial access,
Lead sponsor: Klinikum Arnsberg
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from vascular center of the clinic.

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.


Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 18 years
2. 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
3. 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
4. Subjects have a target lesion(s) with ≥ 70% stenosis (visual estimate) located in the iliac arteries
5. Target lesion is a de novo, restenotic or occluded lesion
6. Reference lumen (vessel) diameter between 5mm and 10 mm
7. The target lesion can be successfully crossed with a guide wire
8. Patient is eligible for transradial access
9. Subject has symptomatic iliac artery disease defined as Rutherford category 2 or higher

Exclusion Criteria:

1. Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study.
2. Subject is with a current medical condition with a life expectancy of less than one year.
3. Pre-existing target iliac artery aneurysm or perforation or dissection
4. 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
5. Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment
6. The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet
7. Subjects with small diameter upper extremity arteries that posed a contraindication to the use of 6F sheath
8. Severe stenosis or calcification of upper extremity arteries
9. Patient height precluding transradial access with a 170 cm long catheter shaft
10. Patient with a history of aortic arch atheroembolism
11. Infrainguinal outflow lesions that need to be treated during the same index procedure
12. Patients with negative bilateral Allen or barbeau tests (Note: vascular access should be done via the left hand where possible)
13. Subject has IFU listed contraindication(s)
14. Subject has in-stent restenosis

Primary outcomes:
measure: Access site complications
timeFrame: 1 hour post procedure
measure: Stroke
timeFrame: 30 days
measure: Death
timeFrame: 30 days
measure: Transradial technical success
timeFrame: Immediately after stent placement via radial access
measure: Number of patients converting to femoral artery access
timeFrame: 1 hour post procedure
Secondary outcomes:
measure: Length of hospital stay [hours]
timeFrame: up to 30 days
measure: Procedure time [min]
timeFrame: Intraoperative
measure: Procedure cost
timeFrame: 1 hour post procedure
measure: Time to ambulation
timeFrame: up to 30 days
measure: Patient satisfaction regarding access site
timeFrame: 24 hours post procedure
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Vascular center of Klinikum Hochsauerland GmbH
city: Bautzen
country: Germany
facility: Oberlausitz Kliniken
city: Lingen
country: Germany
facility: Bonifatius Klinikum Lingen
Study officials:
affiliation: Klinikum Hochsauerland GmbH
name: Michael H Lichtenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: