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

• Sponsor: Biotronik AG (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04830228
• Collaborator: (none)
• Enrollment: 159
• Locations: 13
• Anticipated Duration (Months): 72.7
• Patients Per Site: 12.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease	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 Design

• Study Type: Observational
• Anticipated Enrollment: 159 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Aug 10, 2021
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2027

Outcome Measures

Primary Outcome Measures

1. MAE at 12 months post-index procedure. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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, occluded or in-stent lesion(s) representing atherosclerotic lesion(s) in the iliac arteries

5. Reference lumen (vessel) diameter between 5mm and 10 mm

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 or limbs

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 of the target iliac artery

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, has 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 EVAR (Endovascular Aneurysm Repair) 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 (eGFR < 30 mL/min within 72 hours prior to index procedure)

9. Subject has IFU listed contraindication(s)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LKH Univ.-Klinikum Graz, Ambulanz für Angiologie	Graz		Austria
2	Zol Genk	Genk		Belgium	3600
3	UZ Gent	Gent		Belgium	9000
4	Regionaal Ziekenhuis Heilig Hart Tienen	Tienen		Belgium
5	Az Jan Potaels Vilvoorde	Vilvoorde		Belgium	1800
6	Hôpital Privé du grand Narbonne	Narbonne		France	11100
7	Hôpital Ambroise Paré	Paris		France
8	Klinikum Bayreuth	Bayreuth		Germany	95445
9	Diakonissenkrankenhaus	Flensburg		Germany	24939
10	St. Franziskushospital Münster	Münster		Germany	48145
11	Universitätsklinikum Tübingen	Tübingen		Germany	72076
12	Semmelweis University Hospital	Budapest		Hungary
13	Pauls Stradins Clinical University Hospital	Riga		Latvia

Sponsors and Collaborators

• Biotronik AG

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biotronik AG
• ClinicalTrials.gov Identifier: NCT04830228
• Other Study ID Numbers: C1903
• First Posted: Apr 5, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Biotronik AG: Iliac arteries
• Additional relevant MeSH terms: Peripheral Arterial Disease

Study Results

No Results Posted as of Jul 20, 2022