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

Completed

• Conditions: Peripheral Artery Disease

• Registration Number: NCT02554266
• Lead Sponsor: C. R. Bard

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.

Study Timeline

• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Study Start: 2015-09-29
• Primary Completion: 2018-05-31
• Status Verified: 2019-01
• Study Completion: 2019-11-22
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from major adverse limb related events below the knee and of perioperative death.	30-days	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.
Rate of Target Lesion Revascularization (TLR)	6 months	Defined as clinically-driven target lesion reintervention. All re-interventions at the target limb are captured and adjudicated by a Clinical Events Committee.

Secondary Outcome Measures

Name	Time	Method
Rate of amputations above the ankle at the target limb	1, 6, 12 and 24 months	All events leading to amputations at the target limb will be adjudicated by a Clinical Events Committee.
Primary patency of the target lesion	6, 12 and 24 months	Primary Patency of the target vessel is defined as freedom from total occlusion. Primary patency is assessed by the investigators.
Freedom from clinically-driven Target Lesion Revascularization (TLR)	12 and 24 months	All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee.
Rate of Target vessel reintervention (TVR)	1, 6, 12 and 24 months	All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee.
Rate of unexpected device or drug-related adverse events	1, 6, 12 and 24 months	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.
Rate of reintervention for treatment of thrombosis of the target vessel(s)	1, 6, 12 and 24 months	Arteries may occlude from thrombosis
Rate of reintervention for embolization to its distal vasculature	1, 6, 12 and 24 months	Atherothrombotic debris may occlude the artery downstream and cause distal embolization.
Rate of death	1, 6, 12 and 24 months	All events leading to a patient's death will be adjudicated by a Clinical Events Committee.
Status of ischemic wounds at the target limb	6 and 12 months	Ischemic wounds and their status during the follow-up period will be captured.
Rate of new or recurrent artery lesions at the target limb	6 and 12 months	Artery lesions are captured as Adverse Events.
Change in Rutherford Class at the target limb	6 and 12 months	The Rutherford class is captured from Baseline to study end.

Trial Locations

Locations (26)

Universitaetsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Klinikum Rechts der Isar; 🇩🇪 Munich, Germany

Universitäts-Herzzentrum Freiburg Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Hôpital européen Georges-Pompidou; 🇫🇷 Paris, France

LKH-Univ. Klinikum Graz; 🇦🇹 Graz, Austria

Medical University Vienna, Department of Angiology; 🇦🇹 Vienna, Austria

Klinikum Hochsauerland; 🇩🇪 Arnsberg, Germany

Marienhospital Osnabrück; 🇩🇪 Osnabrück, Germany

Klinikum Klagenfurt am Wörthersee; 🇦🇹 Klagenfurt am Wörthersee, Austria

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

Medical University Vienna, Department of Radiodiagnostic; 🇦🇹 Vienna, Austria

Kreiskrankenhaus Viechtach; 🇩🇪 Viechtach, Germany

Attikon University Hospital; 🇬🇷 Athens, Greece

Patras University Hospital; 🇬🇷 Patra, Greece

Clinica Montevergine; 🇮🇹 Mercogliano, Italy

A.O.U. Citta della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy

King Faisal Hospital and Medical research Center; 🇸🇦 Riyadh, Saudi Arabia

AZ Groeninghe; 🇧🇪 Kortrijk, Belgium

Klinikum Rosenheim; 🇩🇪 Rosenheim, Germany

MEDINOS Klinik Sonneberg; 🇩🇪 Sonneberg, Germany

Policlinico di Monza; 🇮🇹 Monza, Italy

Hospital Santa Marta (C.H.Lisboa Central); 🇵🇹 Lisboa, Portugal

Corporación Sanitaria Parc Taulí; 🇪🇸 Sabadell, Spain

University Hospital Basel; 🇨🇭 Basel, Switzerland

University Hospital of South Manchester; 🇬🇧 Manchester, United Kingdom

University Hospital Zurich; 🇨🇭 Zurich, Switzerland