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

Atherosclerotic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462005
• Other study ID #: Ranger SFA Registry
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Atherosclerotic Disease

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