Status:
ACTIVE_NOT_RECRUITING
BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions
Lead Sponsor:
Biotronik AG
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions
Detailed Description
Prospective, international, multi-center, single-arm study with up to 60 months follow up to evaluate safety and effectiveness of BIOTRONIK's Dynetic-35 stent associated with the use of Passeo-35 Xeo ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrolment
- 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
- De novo, restenotic or occluded lesion(s) representing atherosclerotic lesion(s) in the iliac arteries
- Reference lumen (vessel) diameter between 5mm and 10mm
- The target lesion can be successfully crossed with a guide wire
- The target lesion length is ≤ 100 mm
- Subjects has more than 70% stenosis in target lesion
- Subject has an evidence of a patent profunda femoris or superficial femoral artery in the target limb
- Subject has symptomatic iliac artery occlusive disease defined as Rutherford category 2 or higher eligible for stenting
- 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
- Refuses blood transfusion
- Chronic renal insufficiency (Serum creatinine \>2.5 mg/dL within 30 days prior to index procedure)
- Subject has IFU listed contraindication(s)
- Subject has in-stent restenosis
Exclusion
Key Trial Info
Start Date :
August 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04830228
Start Date
August 10 2021
End Date
February 28 2028
Last Update
December 12 2023
Active Locations (15)
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1
LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
Graz, Austria
2
Zol Genk
Genk, Belgium, 3600
3
UZ Gent
Ghent, Belgium, 9000
4
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Belgium