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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Ballon expandable stent and PTA

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

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

• Study Contact: Name: Damon Judges; Phone Number: +41 0754295286; Email: damon.judges@biotronik.com

Study Locations

• Austria
  • Graz, Austria
    • LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
• Belgium
  • Genk, Belgium, 3600
    • ZOL Genk
  • Gent, Belgium, 9000
    • UZ Gent
  • Tienen, Belgium
    • Regionaal Ziekenhuis Heilig Hart Tienen
  • Vilvoorde, Belgium, 1800
    • Az Jan Potaels Vilvoorde
• France
  • Narbonne, France, 11100
    • Hôpital Privé du Grand Narbonne
  • Paris, France
    • Hopital Ambroise Pare
• Germany
  • Bayreuth, Germany, 95445
    • Klinikum Bayreuth
  • Essen, Germany
    • Universitätsklinikum Essen
  • Flensburg, Germany, 24939
    • Diakonissenkrankenhaus
  • Jena, Germany
    • Universitätsklinikum Jena
  • Münster, Germany, 48145
    • St. Franziskushospital Münster
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Hungary
  • Budapest, Hungary
    • Semmelweis University Hospital
• Latvia
  • Riga, Latvia
    • Pauls Stradins Clinical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Principal Investigator: Marianne Brodmann, Prof. Dr., Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Iliac arteries
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: C1903

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No