Clinical trial NCT02856230: An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)
Official title: An Efficacy and Safety Study to Evaluate Ranger Drug-eluting Balloon for Below the Knee Angioplasty in Patients With Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Lower Limb Ischemia
Peripheral Vascular Diseases
Keywords: Critical limb ischemia
bellow-the-knee angioplasty
drug-eluting balloon
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2016-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety: Number of deaths and major amputations
timeFrame: 6 months
measure: Efficacy: Primary patency (no stenosis >50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)
timeFrame: 6 months
Secondary outcomes:
measure: Composite of all death and major amputation
timeFrame: 12 months
measure: Number of SAEs
timeFrame: 12 months
measure: Number of AEs
timeFrame: 12 months
measure: Late Lumen Loss (LLL)
timeFrame: 6 months
measure: Clinically driven Target Lesion Revascularization (TLR)
timeFrame: 6 and 12 months
measure: Amputation Free Survival
timeFrame: 6 and 12 months
measure: Rate of Wound Healing
timeFrame: 6 and 12 months
measure: Quality of Life
timeFrame: 6 and 12 months
measure: Ulcer diameter
timeFrame: 1, 6 and 12 months
measure: ABI (Ankle-Brachial Index)
timeFrame: 1, 6 and 12 months
measure: Toe pressure
timeFrame: 1, 6 and 12 months
measure: Device success rates
timeFrame: Through angioplasty completion
measure: Technical success rates
timeFrame: Through angioplasty completion
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP - Hopital Europeen Georges-Pompidou Paris, France
state: Ile-de-France
Study officials:
affiliation: AP - HP, Hopital Europeen Georges-Pompidou, Paris, France
name: Marc SAPOVAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: