BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions
NCT ID: NCT04830228
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
160 participants
OBSERVATIONAL
2021-08-10
2028-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Ballon expandable stent and PTA
Endovascular treatment for the peripheral artery disease of the Iliac artery
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Biotronik AG
INDUSTRY
Responsible Party
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Principal Investigators
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Marianne Brodmann, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine
Locations
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LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
Graz, , Austria
Zol Genk
Genk, , Belgium
UZ Gent
Ghent, , Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, , Belgium
Az Jan Potaels Vilvoorde
Vilvoorde, , Belgium
Hôpital Privé du grand Narbonne
Narbonne, , France
Hôpital Ambroise Paré
Paris, , France
Klinikum Bayreuth
Bayreuth, , Germany
Universitätsklinikum Essen
Essen, , Germany
Diakonissenkrankenhaus
Flensburg, , Germany
Universitätsklinikum Jena
Jena, , Germany
St. Franziskushospital Münster
Münster, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Semmelweis University Hospital
Budapest, , Hungary
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Countries
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Other Identifiers
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C1903
Identifier Type: -
Identifier Source: org_study_id