An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)
- Conditions
- Peripheral Vascular DiseasesLower Limb Ischemia
- Interventions
- Device: Ranger SL DEB
- Registration Number
- NCT02856230
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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
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 exclusion criteria:
- Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, superficial femoral or popliteal artery that cannot be treated successfully in the same session
- Previously implanted stent in the target lesions(s)
- Aneurysm in the target vessel
- Acute thrombus in the target limb
- Failure to cross the target lesion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ranger SL DEB angioplasty Ranger SL DEB patients filling general and angiographic inclusion/exclusion criteria will have an BTK angioplasty using one or several Ranger SL drug-eluting balloons
- Primary Outcome Measures
Name Time Method 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)
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
- Secondary Outcome Measures
Name Time Method Number of SAEs 12 months Procedure related or contributed total number of SAEs
Amputation Free Survival 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
Rate of Wound Healing 6 and 12 months Toe pressure 1, 6 and 12 months Toe pressure in the target limb
ABI (Ankle-Brachial Index) 1, 6 and 12 months ABI in the target limb
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 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)
Ulcer diameter 1, 6 and 12 months Ulcer diameter 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
Trial Locations
- Locations (1)
AP-HP - Hopital Europeen Georges-Pompidou Paris, France
🇫🇷Paris, Ile-de-France, France