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

NCT02554266 | Completed DMC

• 1 other identifier: CL0024-01
• Study Type: observational
• Target: 371
• Locations: 11 countries
• Sites: 26

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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• Freedom from major adverse limb related events below the knee and of perioperative death.

  Freedom from the composite of all-cause death, above-ankle amputation or major reintervention, i.e. new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis, of the index limb involving a below-the-knee artery. All these events will be adjudicated by a Clinical Events Committee.

  30-days

• Rate of Target Lesion Revascularization (TLR)

  Defined as clinically-driven target lesion reintervention. All re-interventions at the target limb are captured and adjudicated by a Clinical Events Committee.

  6 months

Secondary Outcomes (11)

• Primary patency of the target lesion

  6, 12 and 24 months

• Freedom from clinically-driven Target Lesion Revascularization (TLR)

  12 and 24 months

• Rate of amputations above the ankle at the target limb

  1, 6, 12 and 24 months

• Rate of Target vessel reintervention (TVR)

  1, 6, 12 and 24 months

• Rate of unexpected device or drug-related adverse events

  1, 6, 12 and 24 months

Interventions

Lutonix 014 Drug Coated Balloon PTA Catheter DEVICE

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

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 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.

You may qualify if:

• Male or non-pregnant, non-breastfeeding female ≥18 years of age;
• Rutherford Clinical Category 3-5;
• Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;
• 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;
• Lesion(s) can be treated with available Lutonix DCB device size matrix per current Instructions for Use (IFU); and
• 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.

You may not qualify if:

• Patients will be excluded if ANY of the following conditions apply:
• 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);
• Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or
• Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (26)

LKH-Univ. Klinikum Graz

Graz, 8036, Austria

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Medical University Vienna, Department of Angiology

Vienna, Austria

Location

Medical University Vienna, Department of Radiodiagnostic

Vienna, Austria

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

AZ Groeninghe

Kortrijk, 8500, Belgium

Location

Hôpital européen Georges-Pompidou

Paris, 75015, France

Location

Klinikum Hochsauerland

Arnsberg, Germany

Location

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

Klinikum Rechts der Isar

Munich, 81675, Germany

Location

Marienhospital Osnabrück

Osnabrück, Germany

Location

Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

MEDINOS Klinik Sonneberg

Sonneberg, Germany

Location

Kreiskrankenhaus Viechtach

Viechtach, Germany

Location

Attikon University Hospital

Athens, Greece

Location

Patras University Hospital

Pátrai, 26504, Greece

Location

Clinica Montevergine

Mercogliano, Italy

Location

Policlinico di Monza

Monza, 20052, Italy

Location

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

Torino, 10126, Italy

Location

Hospital Santa Marta (C.H.Lisboa Central)

Lisbon, 1169-1024, Portugal

Location

King Faisal Hospital and Medical research Center

Riyadh, 3354, Saudi Arabia

Location

Corporación Sanitaria Parc Taulí

Sabadell, 08208, Spain

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

University Hospital of South Manchester

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Dierk Scheinert, MD

  Universitätsklinikum Leipzig: Angiologie

  PRINCIPAL INVESTIGATOR

• Michael Lichtenberg, MD

  Klinikum Arnsberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 18, 2015
• Study Start: September 29, 2015
• Primary Completion: May 31, 2018
• Study Completion: November 22, 2019
• Last Updated: January 13, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); PT (1); ES (1); GB (1); AU (4); GR (2); IT (3); BE (2); SA (1); FR (1); CH (2)