Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.

Ranger DEB All Comers Registry - Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter: An All Comers Registry.

A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon.

Interim analysis will be carried out for every 50 subjects enrolled.

Study Overview

• Status: Completed
• Conditions: Atherosclerotic Disease

• Study Type: Observational
• Enrollment (Actual): 171

Contacts and Locations

Study Locations

• Germany
  • Arnsberg, Germany, 59759
    • Klinikum Hochsauerland, Karolinen-Hospital
  • Bottrop, Germany, 46242
    • Knappschaftskrankenhaus Bottrop
  • Karlsbad-Langensteinbach, Germany, 76307
    • SRH Klinikum Karlsbad-Langensteinbach GmbH
  • Muenchen, Germany, 80331
    • Gefaesspraxis im Tal
  • Trier, Germany, 54292
    • Krankenhaus der Barmherzigen Brüder Trier
• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, CH-1011
      • CHUV, Service de Chirurgie Vasculaire

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

Patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon and who fulfill the in/exclusion criteria at approved investigational centres are eligible for participation in the Ranger DEB-Comers Registry.

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Patient must be willing to sign a a patient informed consent form.
• Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon.
• Target vessel reference diameter 2.5 to 8 mm.

Exclusion Criteria:

• Subjects pregnant or planning to become pregnant during the course of the study.
• Life expectancy of less than 1 year.
• Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ALL COMERS; Patients implanted or scheduled for an implant with a Ranger Drug coated balloon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure.	6 Months
Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention	12 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention	6 and 24 Months
MAE at 12 and 24 months	12 and 24 Months
Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual stenosis (visual assessment)	Intraoperative
Device success, defined as exact deployment of the device according to the IFU (operator assessment)	Intraoperative
Procedural success, defined as the combination of technical success and device success	Intraoperative
Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention)	6, 12 and 24 months
Improvement of at least one Rutherford class at 6, 12 and 24 months (an prior to any reintervention) compared to the pre-procedure Rutherford classification.	6, 12 and 24 months
Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months.	6, 12 and 24 months
Limb salvage, defined as preservation of the treated limb with no need for any amputation at 6, 12 and 24 months.	6, 12 and 24 months
Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score	6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Klinikum Arnsberg
• Collaborators: Boston Scientific Corporation

Publications and helpful links

General Publications

• Lichtenberg M, von Bilderling P, Ranft J, Niemoller K, Grell H, Briner L, Saucy F, Rassaf T, Breuckmann F. Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry. J Cardiovasc Surg (Torino). 2018 Feb;59(1):45-50. doi: 10.23736/S0021-9509.17.10261-2. Epub 2017 Oct 3.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Ranger SFA Registry