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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
First received
Last updated
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
Health authority
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

Study Design


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
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