BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions

Peripheral Artery Disease Clinical Trial

— BIONETIC-I  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04830228
• Other study ID #: C1903
• Status: Active, not recruiting
• Start date: August 10, 2021
• Est. completion date: February 28, 2028

Study information

• Verified date: December 2023
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: February 28, 2028
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Ballon expandable stent and PTA
Endovascular treatment for the peripheral artery disease of the Iliac artery

Locations

Country	Name	City	State
Austria	LKH Univ.-Klinikum Graz, Ambulanz für Angiologie	Graz
Belgium	Zol Genk	Genk
Belgium	UZ Gent	Gent
Belgium	Regionaal Ziekenhuis Heilig Hart Tienen	Tienen
Belgium	Az Jan Potaels Vilvoorde	Vilvoorde
France	Hôpital Privé du grand Narbonne	Narbonne
France	Hôpital Ambroise Paré	Paris
Germany	Klinikum Bayreuth	Bayreuth
Germany	Universitätsklinikum Essen	Essen
Germany	Diakonissenkrankenhaus	Flensburg
Germany	Universitätsklinikum Jena	Jena
Germany	St. Franziskushospital Münster	Münster
Germany	Universitätsklinikum Tübingen	Tübingen
Hungary	Semmelweis University Hospital	Budapest
Latvia	Pauls Stradins Clinical University Hospital	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Hungary,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAE at 12 months post-index procedure.	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.	12 Months