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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT02856230

Collaborator

Boston Scientific Corporation (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Limb Ischemia Peripheral Vascular Diseases	Device: Ranger SL DEB	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Efficacy and Safety Study to Evaluate Ranger Drug-eluting Balloon for Below the Knee Angioplasty in Patients With Critical Limb Ischemia

Actual Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: Ranger SL DEB BTK angioplasty using Ranger SL DEB Other Names: Ranger SL paclitaxel-eluting balloon

Arm

Intervention/Treatment

Experimental: 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

Device: Ranger SL DEB

BTK angioplasty using Ranger SL DEB

Other Names:

Ranger SL paclitaxel-eluting balloon

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
Number of SAEs [12 months]
Procedure related or contributed total number of SAEs
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]
Quality of Life [6 and 12 months]
Quality of Life assessed by EQ5D questionnaires
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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