Clinical trial NCT02554266: Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: Freedom from major adverse limb related events below the knee and of perioperative death.
timeFrame: 30-days
measure: Rate of Target Lesion Revascularization (TLR)
timeFrame: 6 months
Secondary outcomes:
measure: Primary patency of the target lesion
timeFrame: 6, 12 and 24 months
measure: Freedom from clinically-driven Target Lesion Revascularization (TLR)
timeFrame: 12 and 24 months
measure: Rate of amputations above the ankle at the target limb
timeFrame: 1, 6, 12 and 24 months
measure: Rate of Target vessel reintervention (TVR)
timeFrame: 1, 6, 12 and 24 months
measure: Rate of unexpected device or drug-related adverse events
timeFrame: 1, 6, 12 and 24 months
measure: Rate of reintervention for treatment of thrombosis of the target vessel(s)
timeFrame: 1, 6, 12 and 24 months
measure: Rate of reintervention for embolization to its distal vasculature
timeFrame: 1, 6, 12 and 24 months
measure: Rate of death
timeFrame: 1, 6, 12 and 24 months
measure: Status of ischemic wounds at the target limb
timeFrame: 6 and 12 months
measure: Rate of new or recurrent artery lesions at the target limb
timeFrame: 6 and 12 months
measure: Change in Rutherford Class at the target limb
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Angiology
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Radiodiagnostic
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Kortrijk
country: Belgium
facility: AZ Groeninghe
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Munich
country: Germany
facility: Klinikum Rechts der Isar
city: Osnabrück
country: Germany
facility: Marienhospital Osnabrück
city: Rosenheim
country: Germany
facility: Klinikum Rosenheim
city: Sonneberg
country: Germany
facility: MEDINOS Klinik Sonneberg
city: Viechtach
country: Germany
facility: Kreiskrankenhaus Viechtach
city: Athens
country: Greece
facility: Attikon University Hospital
city: Patra
country: Greece
facility: Patras University Hospital
city: Mercogliano
country: Italy
facility: Clinica Montevergine
city: Monza
country: Italy
facility: Policlinico di Monza
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino
city: Lisboa
country: Portugal
facility: Hospital Santa Marta (C.H.Lisboa Central)
city: Riyadh
country: Saudi Arabia
facility: King Faisal Hospital and Medical research Center
city: Sabadell
country: Spain
facility: Corporación Sanitaria Parc Taulí
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
Study officials:
affiliation: Universitätsklinikum Leipzig: Angiologie
name: Dierk Scheinert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Arnsberg
name: Michael Lichtenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: