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

NCT02856230 | Unknown Phase 2

• 2 other identifiers: P151101IDRCB 2016-A00035-46
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Critical limb ischemia; bellow-the-knee angioplasty; drug-eluting balloon

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Composite of all death and major amputation

  12 months

• Number of SAEs

  12 months

• Number of AEs

  12 months

• Late Lumen Loss (LLL)

  6 months

• Clinically driven Target Lesion Revascularization (TLR)

  6 and 12 months

Study Arms (1)

Ranger SL DEB angioplasty

EXPERIMENTAL

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

Interventions

Ranger SL DEB DEVICE

BTK angioplasty using Ranger SL DEB

Also known as: Ranger SL paclitaxel-eluting balloon

Ranger SL DEB angioplasty

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

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

Paris, Île-de-France Region, 75908, France

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Marc SAPOVAL, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: August 4, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: November 1, 2018
• Last Updated: May 18, 2018

Record last verified: 2018-05

Locations

FR (1)