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

Recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT05372952
• Lead Sponsor: Klinikum Arnsberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-13
• Study Start: 2022-07-25
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-05
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	30 days
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
Access site complications	1 hour post procedure	bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion
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%
Stroke	30 days

Secondary Outcome Measures

Name	Time	Method
Procedure time [min]	Intraoperative
Procedure cost	1 hour post procedure	Number and details of auxiliary devices and medication used
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).
Length of hospital stay [hours]	up to 30 days
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

Trial Locations

Locations (3)

Oberlausitz Kliniken; 🇩🇪 Bautzen, Germany

Vascular center of Klinikum Hochsauerland GmbH; 🇩🇪 Arnsberg, Germany

Bonifatius Klinikum Lingen; 🇩🇪 Lingen, Germany