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

Last updated: May 15, 2018
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Vascular Diseases

Claudication

Peripheral Arterial Disease (Pad)

Treatment

N/A

Clinical Study ID

NCT02856230
P151101
IDRCB 2016-A00035-46
  • Ages 18-85
  • All Genders

Study 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

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 priorto 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 inone or more main below the knee vessels

  • Intraluminal recanalization of the target lesion with successful traversal of thetarget lesion and placement of the guidewire into the distal true lumen

  • Reference vessel reference diameter comprised between 2 and 4 mm

Exclusion

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, superficialfemoral 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 Design

Total Participants: 30
Study Start date:
November 01, 2016
Estimated Completion Date:
November 30, 2018

Connect with a study center

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

    Paris, Ile-de-France 75908
    France

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.