Status:
COMPLETED
Investigating the Safety and Efficacy of the Treatment With Luminor DCB and Angiolite DES of iVascular in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia
Lead Sponsor:
Singapore General Hospital
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
This study aims to evaluate the 12 month outcome of the mono- or combination therapy with iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial occlusive disease, pres...
Detailed Description
Extensive arterial occlusions significantly reduces distal arterial perfusion, and may eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic pain, slow...
Eligibility Criteria
Inclusion
- Patient 21 and above
- Patient has critical limb ischemia, presenting a score from 4 to 6 following Rutherford Classification
- Patient is willing to comply with the specified follow-up evaluations at specified time points
- Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a projected life expectancy of at least 12 months
- Prior to enrolment, the guidewire has crossed target lesion
- Patient is eligible for treatment with Luminor Paclitaxel-Eluting Peripheral Balloon Dilation Catheter and Angiolite Drug Eluting Stent
- De novo and post-PTA restenotic lesions located in the tibial arteries suitable for endovascular surgery
- The target lesion is located within the native tibial artery
- The length of the target lesion is \>100mm and considered as TASC C or D lesion according to TASC II Classification
- The target lesion has angiographic evidence of stenosis \>50% or occlusion, which can be passed with standard guidewire manipulation
- Target vessel diameter visually estimated is \>1.5mm and \<4.5mm below the knee
- Either one or two different tibial arteries may be treated. Lesions in the treated segment may be continuous or may have gaps present between stenosis and occlusions.
- Any tibial vessel intervened on must have distal reconstitution above the ankle
- Inflow iliac, SFA and popliteal lesions can be treated during the same procedure using standard angioplasty and/or approved device. These inflow lesions must be treated first prior to consideration of the BTK lesion. The patient can be enrolled if the inflow lesions are treated with good angiographic results (must have \<30% residual stenosis and no evidence of embolization).
- There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow-was established by means of previous endovascular intervention.
Exclusion
- Patient refusing treatment
- Patient is permanently wheelchair-bound or bedridden
- Presence of a stent in the target lesions that was placed during a previous procedure
- Untreated flow-limiting inflow lesions
- Any previous surgery in the same limb
- Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
- Previous bypass surgery in the same limb
- Patient for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated.
- Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
- Perforation at the angioplasty site evidenced by extravasation of contrast medium
- Patients with known hypersensitivity to heparin, including those patients who have a previous incidence of heparin-induced thrombocytopenia (HIT) type II
- Patients with uncorrected bleeding disorders
- Aneurysm located at the level of SFA/popliteal artery
- Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- Severe medical comorbidities (untreated CFA/CHF, severe COPD, metastatic malignancy, dementia, etc.) or other medical conditions that would preclude compliance with the study protocol or 1-year life expectancy
- Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
- Septicemia or bacteremia
- Patient has undrained pus or spreading wet gangrene in the foot that is not controlled at the time of revascularization procedure.
- Episode of acute limb ischemia within the previous 1 month
- Use of thrombectomy, atherectomy, or laser devices during procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure.
- Patient is participating in another research study of a device, medication, biologic or other agent within 30 days which could in the opinion of the investigator affect the results of this study.
Key Trial Info
Start Date :
December 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04073121
Start Date
December 27 2018
End Date
September 30 2020
Last Update
March 17 2021
Active Locations (2)
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1
Singapore General Hospital
Singapore, Singapore, 169608
2
Khoo Teck Puat Hospital
Singapore, Singapore, 768828