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

Peripheral Artery Disease Clinical Trial

— BTKRegistry  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554266
• Other study ID #: CL0024-01
• Status: Completed
• Start date: September 29, 2015
• Est. completion date: November 22, 2019

Study information

• Verified date: January 2019
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: November 22, 2019
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Lutonix 014 Drug Coated Balloon PTA Catheter
Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries

Locations

Country	Name	City	State
Austria	LKH-Univ. Klinikum Graz	Graz
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt am Wörthersee
Austria	Medical University Vienna, Department of Angiology	Vienna
Austria	Medical University Vienna, Department of Radiodiagnostic	Vienna
Belgium	Ziekenhuis Oost Limburg	Genk
Belgium	AZ Groeninghe	Kortrijk
France	Hôpital européen Georges-Pompidou	Paris
Germany	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
Greece	Attikon University Hospital	Athens
Greece	Patras University Hospital	Patra
Italy	Clinica Montevergine	Mercogliano
Italy	Policlinico di Monza	Monza
Italy	A.O.U. Citta della Salute e della Scienza di Torino	Torino
Portugal	Hospital Santa Marta (C.H.Lisboa Central)	Lisboa
Saudi Arabia	King Faisal Hospital and Medical research Center	Riyadh
Spain	Corporación Sanitaria Parc Taulí	Sabadell
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Zurich	Zurich
United Kingdom	University Hospital of South Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of reintervention for treatment of thrombosis of the target vessel(s)	Arteries may occlude from thrombosis	1, 6, 12 and 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of new or recurrent artery lesions at the target limb	Artery lesions are captured as Adverse Events.	6 and 12 months
Secondary	Change in Rutherford Class at the target limb	The Rutherford class is captured from Baseline to study end.	6 and 12 months