Atherosclerotic Disease
Conditions
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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Klinikum Arnsberg
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
| 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 |
| 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 |
| Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention) | 6, 12 and 24 months |
Countries
Germany, Switzerland
Outcome results
None listed