NCT02462005

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

3.3 years

First QC Date

May 27, 2015

Last Update Submit

January 7, 2020

Conditions

Atherosclerotic Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

ALL COMERS

Patients implanted or scheduled for an implant with a Ranger Drug coated balloon.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Klinikum Hochsauerland, Karolinen-Hospital

Arnsberg, 59759, Germany

Location

Knappschaftskrankenhaus Bottrop

Bottrop, 46242, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad-Langensteinbach, 76307, Germany

Location

Gefaesspraxis im Tal

München, 80331, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier

Trier, 54292, Germany

Location

CHUV, Service de Chirurgie Vasculaire

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 28980462DERIVED

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2015

First Posted

June 3, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2018

Study Completion

May 1, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations

CH(1)DE(5)