Lower Limb Ischemia, Peripheral Vascular Diseases
Conditions
Keywords
Critical limb ischemia, bellow-the-knee angioplasty, drug-eluting balloon
Brief summary
Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel disease. A successful recanalization of foot artery was related to a higher ulcer healing and a reduction of major amputation. Moreover absence of revascularization in a patient with critical limb ischemia is an independent risk factor for mortality. Despite the introduction of new devices dedicated to below the knee vessel disease treatment, with the development of guides and conical balloons, long term patency outcomes are still poor. Restenosis was observed in more than two thirds of patients within 3 months after angioplasty of tibial arteries with a high target lesions revascularization. These re-interventions are characterized by a higher morbidity and mortality due to several comorbidities associated to these patients. These data confirm the need to obtain more lasting results in order to improve long-term outcomes of these patients. Recently, the use of drug-eluting balloons (DEB) has revealed an increase in patency after angioplasty of the femoral artery. On the contrary, results for BTK arteries angioplasty have shown controversial results. The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb ischemia.
Interventions
DEVICERanger SL DEB
BTK angioplasty using Ranger SL DEB
Sponsors
Boston Scientific Corporation
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria : * Age ≥18 years and ≤85 years * Patient signed an approved consent form * Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6 * Menopausal or under contraception for women * Negative serum β-HCG for women of childbearing age Angiographic Inclusion Criteria : * Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in one or more main below the knee vessels * Intraluminal recanalization of the target lesion with successful traversal of the target lesion and placement of the guidewire into the distal true lumen * Reference vessel reference diameter comprised between 2 and 4 mm
Exclusion criteria
General non-inclusion criteria: * Patient with known hypersensitivity to paclitaxel * Patient unwilling or unlikely to comply with Follow-Up schedule * Life expectancy \<1 year (investigator's appreciation) * Planned major index limb amputation * Pregnant or breast feeding women Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of deaths and major amputations | 6 months | Number of deaths and major amputations (any amputation above the knee) at 6 months after procedure |
| Efficacy: Primary patency (no stenosis >50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA) | 6 months | Primary patency (no stenosis \>50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of AEs | 12 months | Procedure related or contributed total number of AEs |
| Late Lumen Loss (LLL) | 6 months | Late Lumen Loss (LLL) of the Target Lesion measured by Quantitative Vascular Angiography (QVA) |
| Clinically driven Target Lesion Revascularization (TLR) | 6 and 12 months | Clinically driven TLR is defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and/or increase in size of pre-existing wounds and / or occurrence of a new wound(s) |
| Amputation Free Survival | 6 and 12 months | — |
| Rate of Wound Healing | 6 and 12 months | — |
| Composite of all death and major amputation | 12 months | Number of deaths and major amputations (any amputation above the knee) at 12 months after procedure |
| Ulcer diameter | 1, 6 and 12 months | Ulcer diameter in the target limb |
| ABI (Ankle-Brachial Index) | 1, 6 and 12 months | ABI in the target limb |
| Toe pressure | 1, 6 and 12 months | Toe pressure in the target limb |
| Device success rates | Through angioplasty completion | Percentage of exact deployment of the device according to the instructions for use as documented with suitable imaging modalities |
| Technical success rates | Through angioplasty completion | Percentage of successful vascular access, completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography |
| Quality of Life | 6 and 12 months | Quality of Life assessed by EQ5D questionnaires |
| Number of SAEs | 12 months | Procedure related or contributed total number of SAEs |
Countries
France
Outcome results
None listed