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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372952
• Other study ID #: ASL202201
• Status: Recruiting
• Start date: July 25, 2022
• Est. completion date: August 2023

Study information

• Verified date: January 2023
• Source: Klinikum Arnsberg
• Contact: Study office of Vascular Center
• Phone: +49 2932 952
• Email: studienzentrum-angiologie[@]klinikum-hochsauerland.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Dynetic-35 Peripheral Balloon-Expandable Stent System
Stenotic iliac lesions will be treated with the Dynetic 35 stent via a radial access

Locations

Country	Name	City	State
Germany	Vascular center of Klinikum Hochsauerland GmbH	Arnsberg
Germany	Oberlausitz Kliniken	Bautzen
Germany	Bonifatius Klinikum Lingen	Lingen

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Arnsberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Access site complications	bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion	1 hour post procedure
Primary	Stroke		30 days
Primary	Death		30 days
Primary	Transradial technical success	Successful delivery of the Dynetic-35 stent at the lesion site with residual stenosis of = 30%	Immediately after stent placement via radial access
Primary	Number of patients converting to femoral artery access	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	1 hour post procedure
Secondary	Length of hospital stay [hours]		up to 30 days
Secondary	Procedure time [min]		Intraoperative
Secondary	Procedure cost	Number and details of auxiliary devices and medication used	1 hour post procedure
Secondary	Time to ambulation	Time between patient left the cath lab/operating theatre, and patient was able to walk 100 meters and the access site remained stable	up to 30 days
Secondary	Patient satisfaction regarding access site	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).	24 hours post procedure