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

A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon Percutaneous Transluminal Angioplasty (PTA) Catheter for Treatment of Below-the-Knee (BTK) Arteries

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Lutonix 014 Drug Coated Balloon PTA Catheter

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.

• Study Type: Observational
• Enrollment (Actual): 371

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • LKH-Univ. Klinikum Graz
  • Klagenfurt am Wörthersee, Austria, 9020
    • Klinikum Klagenfurt am Wörthersee
  • Vienna, Austria
    • Medical University Vienna, Department of Angiology
  • Vienna, Austria
    • Medical University Vienna, Department of Radiodiagnostic
• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg
  • Kortrijk, Belgium, 8500
    • AZ Groeninghe
• France
  • Paris, France, 75015
    • Hopital Europeen Georges-Pompidou
• Germany
  • Arnsberg, Germany
    • Klinikum Hochsauerland
  • Bad Krozingen, Germany, 79189
    • Universitäts-Herzzentrum Freiburg Bad Krozingen
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Munich, Germany, 81675
    • Klinikum Rechts der Isar
  • Osnabrück, Germany
    • Marienhospital Osnabrück
  • Rosenheim, Germany, 83022
    • Klinikum Rosenheim
  • Sonneberg, Germany
    • MEDINOS Klinik Sonneberg
  • Viechtach, Germany
    • Kreiskrankenhaus Viechtach
• Greece
  • Athens, Greece
    • Attikon University Hospital
  • Patra, Greece, 26504
    • Patras University Hospital
• Italy
  • Mercogliano, Italy
    • Clinica Montevergine
  • Monza, Italy, 20052
    • Policlinico di Monza
  • Torino, Italy, 10126
    • A.O.U. Città della Salute e della Scienza di Torino
• Portugal
  • Lisboa, Portugal, 1169-1024
    • Hospital Santa Marta (C.H.Lisboa Central)
• Saudi Arabia
  • Riyadh, Saudi Arabia, 3354
    • King Faisal Hospital and Medical research Center
• Spain
  • Sabadell, Spain, 08208
    • Corporacion Sanitaria Parc Tauli
• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
  • Zurich, Switzerland
    • University Hospital Zurich
• United Kingdom
  • Manchester, United Kingdom
    • University Hospital of South Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency of the target lesion	Primary Patency of the target vessel is defined as freedom from total occlusion. Primary patency is assessed by the investigators.	6, 12 and 24 months
Freedom from clinically-driven Target Lesion Revascularization (TLR)	All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee.	12 and 24 months
Rate of amputations above the ankle at the target limb	All events leading to amputations at the target limb will be adjudicated by a Clinical Events Committee.	1, 6, 12 and 24 months
Rate of Target vessel reintervention (TVR)	All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee.	1, 6, 12 and 24 months
Rate of unexpected device or drug-related adverse events	Unexpected device or drug-related adverse events are those events that are related to the device or drug, but are not listed in the potential adverse event section of the Instructions For Use.	1, 6, 12 and 24 months
Rate of reintervention for treatment of thrombosis of the target vessel(s)	Arteries may occlude from thrombosis	1, 6, 12 and 24 months
Rate of reintervention for embolization to its distal vasculature	Atherothrombotic debris may occlude the artery downstream and cause distal embolization.	1, 6, 12 and 24 months
Rate of death	All events leading to a patient's death will be adjudicated by a Clinical Events Committee.	1, 6, 12 and 24 months
Status of ischemic wounds at the target limb	Ischemic wounds and their status during the follow-up period will be captured.	6 and 12 months
Rate of new or recurrent artery lesions at the target limb	Artery lesions are captured as Adverse Events.	6 and 12 months
Change in Rutherford Class at the target limb	The Rutherford class is captured from Baseline to study end.	6 and 12 months

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Dierk Scheinert, MD, Universitätsklinikum Leipzig: Angiologie

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2015
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: September 14, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: CL0024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO