Peripheral Artery Disease
Conditions
Keywords
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
Interventions
DEVICEBallon expandable stent and PTA
Endovascular treatment for the peripheral artery disease of the Iliac artery
Sponsors
Biotronik AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAE at 12 months post-index procedure. | 12 Months | The MAE includes device or procedure related death within 30 days post index procedure, cdTLR, and major index limb amputation up to 12 months post index procedure. |
Countries
Austria, Belgium, France, Germany, Hungary, Latvia
Outcome results
None listed