Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore (PRESTIGE)

Singapore Health Services (SingHealth)

Status

Completed

Conditions

Critical Limb Ischemia

Treatments

Device: Drug Coated Balloon

Study type

Interventional

Funder types

Other

Identifiers

NCT04071782

CIRB 2019/2121

Details and patient eligibility

About

The objective of this clinical investigation is to evaluate the 6-month outcome of the Selution Sirolimus-coated Balloon for the treatment of long tibial occlusive disease (TASC C and D) in patients with Critical Limb Ischemia (CLI)

Full description

Extensive arterial occlusion significantly reduces arterial perfusion, and may eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic pain, slow healing wounds at lower extremity and gangrene. It places patients with multi-segment occlusion at high risks of amputations and mortality.

The treatment methods for such long occlusive lesions are limited. Traditionally, the standard of care would be surgical revascularization. This is because lesion length have bee identified in several studies as an independent risk factor for the development of restenosis after angioplasty and/or stenting. However, thanks to recent advances in endovascular techniques, such as the utilization of subintimal technique for crossing long segment occlusions, it is now possible to employ endovascular techniques for suitable patients.

The re-establishment of an in-line flow, even if only temporary, can allow tissue healing, which is vital in achieving limb salvage. In addition, the use of Drug Coated Balloons (DCB) and Drug Eluting Stents (DES) can potentially reduce restenosis rate.

To date, there are few studies that have evaluated the performance of DCB in lesions that are longer than 10cm. We hope to evaluate the performance of the Selution DCB when used in treatment of such lesions.

Enrollment

25 patients

Sex

All

Ages

21 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age of subject is > 21 years old
Patient has Critical Limb Ischemia, presenting a score from 4 to 6 following Rutherford Classification
Patient is willing to comply with specified follow-up evaluations at the specified times
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 and has not suffered an MI within past 30 days
Prior to enrolment, the guidewire has crossed the target lesion.
De novo and post-PTA restenotic lesions located in the tibial arteries suitable for endovascular therapy
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 the TASC II Classification
The target lesion has angiographic evidence of stenosis >50% or occlusion, which has been passed with standard guidewire manipulation and predilated to <30% residual stenosis using either POBA or high pressure POBA. No other adjunctive devices have been used to prepare the lesion (example - scoring balloons, rotablator, atherectomy device)
Target vessel diameter 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 stenoses 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 devices. These inflow lesions must be treated first prior to consideration of treatment of the BTK lesions. 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 through the ankle and into the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention.

Exclusion criteria

Patient refusing treatment
Patient is permanently wheel-chair bound or bedridden
Presence of a stent in the target lesion that was placed during a previous procedure
The intervention is being performed in preparation of a planned amputation
Untreated flow-limiting inflow lesions
Any previous surgery in the target vessels (including prior ipsilateral crural bypass)
Previous bypass surgery in the same limb
Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
Perforation at the angioplasty site evidenced by extravasation of contrast medium.
Untreatable lesion located at the distal outflow arteries
Patients with uncorrectable bleeding disorders
Aneurysm located at the level of the SFA/popliteal artery
Non-artherosclerotic disease resulting in occlusion
Any condition which prevents patients from complying with the study protocol or if patient has a life expectancy of < 1 year.
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
Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb)
Episode of thrombectomy, cutting balloon, lithotripsy, 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
The patient is currently breast-feeding, pregnant or intends to become pregnant
Subject receiving immunosuppression therapy, or has known serious immunosuppression therapy, or has known serious immunosuppressive disease (e.g. human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy. The patient should also not receive inhibitors of CYP3A (such as Itraconazole, Erythromycin) or inducer of CYP3A (such as Rifampin) within 90 days following 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
Patients with lesion to be treated with residual stenosis after POBA of >30%