Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

NCT ID: NCT02554266

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 371 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-29
• Study Completion Date: 2019-11-22

Brief Summary

The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

Detailed Description

Patients will be treated according to hospital routine with anticipated visits 30 days, 6 months, 12months and 24 months after the index procedure. Data on Rutherford grade, wound healing, patency of the target lesion, concomitant antiplatelet medication and Adverse Events will be collected.

Conditions

Peripheral Artery Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Lutonix 014 Drug Coated Balloon PTA Catheter

Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or non-pregnant, non-breastfeeding female ≥18 years of age;

2. Rutherford Clinical Category 3-5;

3. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;

4. Significant stenosis (≥70%) or occlusion of one or more native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment;

5. Lesion(s) can be treated with available Lutonix DCB device size matrix per current Instructions for Use (IFU); and

6. Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (<50% residual stenosis) inframalleolar outflow vessel (planned treatment below-the-ankle is not allowed).

NOTE: Outflow must be assessed AFTER pre-dilatation NOTE: More than one artery allowed, but each target vessel MUST demonstrate inline inframalleolar outflow.

Exclusion Criteria

Patients will be excluded if ANY of the following conditions apply:

1. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix BTK registry);

2. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or

3. Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dierk Scheinert, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Leipzig: Angiologie

Michael Lichtenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Arnsberg

Locations

LKH-Univ. Klinikum Graz

Graz, , Austria

Klinikum Klagenfurt am Wörthersee

Klagenfurt, , Austria

Medical University Vienna, Department of Angiology

Vienna, , Austria

Medical University Vienna, Department of Radiodiagnostic

Vienna, , Austria

Ziekenhuis Oost Limburg

Genk, , Belgium

AZ Groeninghe

Kortrijk, , Belgium

Hôpital européen Georges-Pompidou

Paris, , France

Klinikum Hochsauerland

Arnsberg, , Germany

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, , Germany

Universitaetsklinikum Leipzig

Leipzig, , Germany

Klinikum Rechts der Isar

Munich, , Germany

Marienhospital Osnabrück

Osnabrück, , Germany

Klinikum Rosenheim

Rosenheim, , Germany

MEDINOS Klinik Sonneberg

Sonneberg, , Germany

Kreiskrankenhaus Viechtach

Viechtach, , Germany

Attikon University Hospital

Athens, , Greece

Patras University Hospital

Pátrai, , Greece

Clinica Montevergine

Mercogliano, , Italy

Policlinico di Monza

Monza, , Italy

A.O.U. Citta della Salute e della Scienza di Torino

Torino, , Italy

Hospital Santa Marta (C.H.Lisboa Central)

Lisbon, , Portugal

King Faisal Hospital and Medical research Center

Riyadh, , Saudi Arabia

Corporación Sanitaria Parc Taulí

Sabadell, , Spain

University Hospital Basel

Basel, , Switzerland

University Hospital Zurich

Zurich, , Switzerland

University Hospital of South Manchester

Manchester, , United Kingdom

Countries

Austria; Belgium; France; Germany; Greece; Italy; Portugal; Saudi Arabia; Spain; Switzerland; United Kingdom

Other Identifiers

CL0024-01

Identifier Type: -

Identifier Source: org_study_id