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

Peripheral Vascular Diseases Clinical Trial

— RANGER-BTK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02856230
• Other study ID #: P151101
• Secondary ID: IDRCB 2016-A0003
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: May 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: November 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Ischemia
• Lower Limb Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Ranger SL DEB
BTK angioplasty using Ranger SL DEB

Locations

Country	Name	City	State
France	AP-HP - Hopital Europeen Georges-Pompidou Paris, France	Paris	Ile-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Boston Scientific Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Number of SAEs	Procedure related or contributed total number of SAEs	12 months
Secondary	Number of AEs	Procedure related or contributed total number of AEs	12 months
Secondary	Late Lumen Loss (LLL)	Late Lumen Loss (LLL) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)	6 months
Secondary	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
Secondary	Amputation Free Survival		6 and 12 months
Secondary	Rate of Wound Healing		6 and 12 months
Secondary	Quality of Life	Quality of Life assessed by EQ5D questionnaires	6 and 12 months
Secondary	Ulcer diameter	Ulcer diameter in the target limb	1, 6 and 12 months
Secondary	ABI (Ankle-Brachial Index)	ABI in the target limb	1, 6 and 12 months
Secondary	Toe pressure	Toe pressure in the target limb	1, 6 and 12 months
Secondary	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
Secondary	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