BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions (BIONETIC-I)

Biotronik

Status: Active, not recruiting

Conditions: Peripheral Artery Disease

Treatments: Device: Ballon expandable stent and PTA

Study type: Observational

Funder types: Industry

Identifiers

NCT04830228

C1903

Details and patient eligibility

About

BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions

Full 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

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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