Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALL COMERS | Patients implanted or scheduled for an implant with a Ranger Drug coated balloon. |
Not provided
| Measure | Description | 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 |
| Measure | Description | 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Hochsauerland, Karolinen-Hospital | Arnsberg | 59759 | Germany | |||
| Knappschaftskrankenhaus Bottrop |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28980462 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Bottrop |
| 46242 |
| Germany |
| SRH Klinikum Karlsbad-Langensteinbach GmbH | Karlsbad-Langensteinbach | 76307 | Germany |
| Gefaesspraxis im Tal | München | 80331 | Germany |
| Krankenhaus der Barmherzigen Brüder Trier | Trier | 54292 | Germany |
| CHUV, Service de Chirurgie Vasculaire | Lausanne | Canton of Vaud | CH-1011 | Switzerland |