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

NCT ID: NCT02856230

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-11-30

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.

Conditions

Lower Limb Ischemia; Peripheral Vascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranger SL DEB angioplasty

patients filling general and angiographic inclusion/exclusion criteria will have an BTK angioplasty using one or several Ranger SL drug-eluting balloons

Group Type: EXPERIMENTAL

Ranger SL DEB

Intervention Type: DEVICE

BTK angioplasty using Ranger SL DEB

Interventions

Ranger SL DEB

BTK angioplasty using Ranger SL DEB

Intervention Type: DEVICE

Other Intervention Names

Ranger SL paclitaxel-eluting balloon

Eligibility Criteria

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

• 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

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc SAPOVAL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AP - HP, Hopital Europeen Georges-Pompidou, Paris, France

Locations

AP-HP - Hopital Europeen Georges-Pompidou Paris, France

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

IDRCB 2016-A00035-46

Identifier Type: OTHER

Identifier Source: secondary_id

P151101

Identifier Type: -

Identifier Source: org_study_id