An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)

Assistance Publique - Hôpitaux de Paris30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Limb Ischemia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

Safety: Number of deaths and major amputations

Number of deaths and major amputations (any amputation above the knee) at 6 months after procedure

Time frame: 6 months

Efficacy: Primary patency (no stenosis >50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)

Primary patency (no stenosis \>50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)

Time frame: 6 months

Secondary Outcomes

Composite of all death and major amputation

Number of deaths and major amputations (any amputation above the knee) at 12 months after procedure

Time frame: 12 months

Number of SAEs

Procedure related or contributed total number of SAEs

Time frame: 12 months

Number of AEs

Procedure related or contributed total number of AEs

Time frame: 12 months

Late Lumen Loss (LLL)

Late Lumen Loss (LLL) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)

Time frame: 6 months

Clinically driven Target Lesion Revascularization (TLR)

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)

Time frame: 6 and 12 months

Amputation Free Survival

Time frame: 6 and 12 months

Rate of Wound Healing

Time frame: 6 and 12 months

Quality of Life

Quality of Life assessed by EQ5D questionnaires

Time frame: 6 and 12 months

Ulcer diameter

Ulcer diameter in the target limb

Time frame: 1, 6 and 12 months

ABI (Ankle-Brachial Index)

ABI in the target limb

Time frame: 1, 6 and 12 months

Toe pressure

Toe pressure in the target limb

Time frame: 1, 6 and 12 months

Device success rates

Percentage of exact deployment of the device according to the instructions for use as documented with suitable imaging modalities

Time frame: Through angioplasty completion

Technical success rates

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

Time frame: Through angioplasty completion

An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes