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

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

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 Overview

• Status: Unknown
• Conditions: Peripheral Vascular Diseases; Lower Limb Ischemia
• Intervention / Treatment: Device: Ranger SL DEB

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75908
      • AP-HP - Hôpital Européen Georges-Pompidou Paris, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Number of deaths and major amputations	Number of deaths and major amputations (any amputation above the knee) at 6 months after procedure	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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all death and major amputation	Number of deaths and major amputations (any amputation above the knee) at 12 months after procedure	12 months
Number of SAEs	Procedure related or contributed total number of SAEs	12 months
Number of AEs	Procedure related or contributed total number of AEs	12 months
Late Lumen Loss (LLL)	Late Lumen Loss (LLL) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)	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)	6 and 12 months
Amputation Free Survival		6 and 12 months
Rate of Wound Healing		6 and 12 months
Quality of Life	Quality of Life assessed by EQ5D questionnaires	6 and 12 months
Ulcer diameter	Ulcer diameter in the target limb	1, 6 and 12 months
ABI (Ankle-Brachial Index)	ABI in the target limb	1, 6 and 12 months
Toe pressure	Toe pressure in the target limb	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	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	Through angioplasty completion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Marc SAPOVAL, MD, PhD, AP - HP, Hôpital Européen Georges-Pompidou, Paris, France

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 31, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Critical limb ischemia; drug-eluting balloon; bellow-the-knee angioplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: P151101; IDRCB 2016-A00035-46 (Other Identifier: Agence Nationale de Securite du Medicament et des Produits de Sante)