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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02462005
Other study ID # Ranger SFA Registry
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date May 2019

Study information

Verified date January 2020
Source Klinikum Arnsberg
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date May 2019
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Klinikum Hochsauerland, Karolinen-Hospital Arnsberg
Germany Knappschaftskrankenhaus Bottrop Bottrop
Germany SRH Klinikum Karlsbad-Langensteinbach GmbH Karlsbad-Langensteinbach
Germany Gefaesspraxis im Tal Muenchen
Germany Krankenhaus der Barmherzigen Brüder Trier Trier
Switzerland CHUV, Service de Chirurgie Vasculaire Lausanne Vaud

Sponsors (2)

Lead Sponsor Collaborator
Klinikum Arnsberg Boston Scientific Corporation

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention 12 Months
Secondary Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention 6 and 24 Months
Secondary MAE at 12 and 24 months 12 and 24 Months
Secondary Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with = 50% residual stenosis (visual assessment) Intraoperative
Secondary Device success, defined as exact deployment of the device according to the IFU (operator assessment) Intraoperative
Secondary Procedural success, defined as the combination of technical success and device success Intraoperative
Secondary Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention) 6, 12 and 24 months
Secondary 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
Secondary Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months. 6, 12 and 24 months
Secondary 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
Secondary Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score 6, 12 and 24 months
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