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

NCT04830228 | Active Not Recruiting

• 1 other identifier: C1903
• Study Type: observational
• Target: 160
• Locations: 6 countries
• Sites: 15

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

Conditions

Peripheral Artery Disease

Keywords

Iliac arteries

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Ballon expandable stent and PTA DEVICE

Endovascular treatment for the peripheral artery disease of the Iliac artery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrolment
• 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
• 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
• De novo, restenotic or occluded lesion(s) representing atherosclerotic lesion(s) in the iliac arteries
• Reference lumen (vessel) diameter between 5mm and 10mm
• The target lesion can be successfully crossed with a guide wire
• The target lesion length is ≤ 100 mm
• Subjects has more than 70% stenosis in target lesion
• Subject has an evidence of a patent profunda femoris or superficial femoral artery in the target limb
• Subject has symptomatic iliac artery occlusive disease defined as Rutherford category 2 or higher eligible for stenting

You may not qualify if:

• Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study.
• Subject is with a current medical condition with a life expectancy of less than one year.
• Pre-existing target iliac artery aneurysm or perforation or dissection
• 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
• Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment
• The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet
• Refuses blood transfusion
• Chronic renal insufficiency (Serum creatinine \>2.5 mg/dL within 30 days prior to index procedure)
• Subject has IFU listed contraindication(s)
• Subject has in-stent restenosis

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (15)

LKH Univ.-Klinikum Graz, Ambulanz für Angiologie

Graz, Austria

Location

Zol Genk

Genk, 3600, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, Belgium

Location

Az Jan Potaels Vilvoorde

Vilvoorde, 1800, Belgium

Location

Hôpital Privé du grand Narbonne

Narbonne, 11100, France

Location

Hôpital Ambroise Paré

Paris, France

Location

Klinikum Bayreuth

Bayreuth, 95445, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Diakonissenkrankenhaus

Flensburg, 24939, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

St. Franziskushospital Münster

Münster, 48145, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Semmelweis University Hospital

Budapest, Hungary

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Related Publications (1)

• Brodmann M, Nemes B, Moreels N, Austermann M, Schmehl J, Robijn J, Rammos C, Muller-Hulsbeck S, Keirse K, Coscas R, Kupcs K, Augustin AM, Moebius-Winkler S, Lichtenberg M, Lansink W. Dynetic-35 cobalt chromium balloon-expandable stent for iliac lesions: 12-month results of the BIONETIC-I multi-center study. CVIR Endovasc. 2025 Dec 13;8(1):114. doi: 10.1186/s42155-025-00633-z.

  PMID: 41389246 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Marianne Brodmann, Prof. Dr.

  Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: August 10, 2021
• Primary Completion: February 28, 2023
• Study Completion (Estimated): February 28, 2028
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

DE (6); BE (4); HU (1); FR (2); AU (1); LA (1)