Clinical trial NCT04830228: BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions
Official title: BIOTRONIK Dynetic-35 for the Treatment of Peripheral Iliac Lesions, Using the Cobalt Chromium Balloon-expandable Dynetic-35 Stent in Association With Passeo-35 Xeo Peripheral Dilation Catheter
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Peripheral Artery Disease
Keywords: Iliac arteries
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo, restenotic and in-stent atherosclerotic lesions in iliac arteries

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 for the treatment of peripheral artery disease (PAD) in subjects with atherosclerotic disease in iliac arteries

Eligibility criteria: Inclusion Criteria

1. Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrolment
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. De novo, restenotic or occluded lesion(s) representing atherosclerotic lesion(s) in the iliac arteries
5. Reference lumen (vessel) diameter between 5mm and 10mm
6. The target lesion can be successfully crossed with a guide wire
7. The target lesion length is ≤ 100 mm
8. Subjects has more than 70% stenosis in target lesion
9. Subject has an evidence of a patent profunda femoris or superficial femoral artery in the target limb
10. Subject has symptomatic iliac artery occlusive disease defined as Rutherford category 2 or higher eligible for stenting

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. Refuses blood transfusion
8. Chronic renal insufficiency (Serum creatinine \>2.5 mg/dL within 30 days prior to index procedure)
9. Subject has IFU listed contraindication(s)
10. Subject has in-stent restenosis

Primary outcomes:
measure: MAE at 12 months post-index procedure.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
city: Genk
country: Belgium
facility: Zol Genk
city: Gent
country: Belgium
facility: UZ Gent
city: Tienen
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart Tienen
city: Vilvoorde
country: Belgium
facility: Az Jan Potaels Vilvoorde
city: Narbonne
country: France
facility: Hôpital Privé du grand Narbonne
city: Paris
country: France
facility: Hôpital Ambroise Paré
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Flensburg
country: Germany
facility: Diakonissenkrankenhaus
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Münster
country: Germany
facility: St. Franziskushospital Münster
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Budapest
country: Hungary
facility: Semmelweis University Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
Study officials:
affiliation: Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine
name: Marianne Brodmann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: