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

December 11, 2023 updated by: Biotronik AG

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Hôpital Ambroise Paré
  • Germany
      • Bayreuth, Germany, 95445
        • Klinikum Bayreuth
      • Essen, Germany
        • Universitätsklinikum Essen
      • Flensburg, Germany, 24939
        • Diakonissenkrankenhaus
      • Jena, Germany
        • Universitatsklinikum Jena
      • Münster, Germany, 48145
        • St. Franziskushospital Münster
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen
  • Hungary
      • Budapest, Hungary
        • Semmelweis University Hospital
  • Latvia
      • Riga, Latvia
        • Pauls Stradins Clinical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MAE at 12 months post-index procedure.
Time Frame: 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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marianne Brodmann, Prof. Dr., Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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