Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ALL COMERS Patients implanted or scheduled for an implant with a Ranger Drug coated balloon. |
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years.
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Patient must be willing to sign a a patient informed consent form.
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Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon.
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Target vessel reference diameter 2.5 to 8 mm.
Exclusion Criteria:
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Subjects pregnant or planning to become pregnant during the course of the study.
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Life expectancy of less than 1 year.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum Hochsauerland, Karolinen-Hospital | Arnsberg | Germany | 59759 | |
| 2 | Knappschaftskrankenhaus Bottrop | Bottrop | Germany | 46242 | |
| 3 | SRH Klinikum Karlsbad-Langensteinbach GmbH | Karlsbad-Langensteinbach | Germany | 76307 | |
| 4 | Gefaesspraxis im Tal | Muenchen | Germany | 80331 | |
| 5 | Krankenhaus der Barmherzigen Brüder Trier | Trier | Germany | 54292 | |
| 6 | CHUV, Service de Chirurgie Vasculaire | Lausanne | Vaud | Switzerland | CH-1011 |
Sponsors and Collaborators
- Klinikum Arnsberg
- Boston Scientific Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Ranger SFA Registry