Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore

NCT04534257 | Unknown DMC

• 1 other identifier: 2020/2605
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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 been 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) can potentially reduce restenosis rate, as Sirolimus have an anti-proliferative effect. To date, there are few studies that have evaluated the performance of DCB in lesions that are longer than 10cm. The investigators hope to evaluate the performance of the Selution DCB when used in treatment of such lesions

Conditions

Critical Lower Limb Ischemia; Peripheral Artery Disease

Keywords

Drug-eluting balloon; Sirolimus

Outcome Measures

Primary Outcomes (2)

• Freedom from Major Adverse Events

  Composite of freedom from device- and procedure-related mortality

  30 days post-index procedure

• Freedom from clinically driven target lesion revascularization

  Any re-intervention performed for more than 50% diameter stenosis at target lesion after documentation of recurrent or unresolved and continuing clinical symptoms

  6 months post-index procedure

Secondary Outcomes (7)

• Primary patency

  6 and 12 months post-index procedure

• Technical Success

  Immediately post-op

• Freedom from clinically-drive target lesion revascularization

  12 month post-index procedure

• Clinical success at follow-up

  6 and 12 months post index procedure

• Wound healing

  6 months post-index procedure

Study Arms (1)

Angioplasty with SELUTION Sirolimus DCB

EXPERIMENTAL

Subjects with infra-inguinal occlusive lesions will be treated with SELUTION Sirolimus DCB

Device: SELUTION Sirolimus DCB

Interventions

SELUTION Sirolimus DCB DEVICE

Suitable lesions will be treated with SELUTION Sirolimus DCB

Angioplasty with SELUTION Sirolimus DCB

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of subject is \> 21 years old.
• Patient has critical limb ischemia, presenting a score from 4 to 6 following Rutherford classification
• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient is willing to comply with specified follow-up evaluations at the specified times
• 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 re-stenotic lesions located in the SFA, popliteal and/or tibial arteries suitable for endovascular therapy
• The target lesion is located within the SFA, popliteal and/or tibial and infra-malleolar arteries
• The length of the target lesion is \> 50mm 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 pre-dilated to \<30% residual stenosis using any combination of POBA, high pressure POBA, scoring balloon, or rotablator.
• Target vessel diameter visually estimated is \>1.5mm and \<7 mm below the groin to the foot
• Lesions in the treated segment may be continuous or may have gaps present between stenoses and occlusions
• The target lesion has both patent inflow and at least one patent outflow tract extending to below the ankle. If required, the vessels of the ankle and foot should be treated with pre-dilatation and deployment of an appropriated sized balloon (i.e. smaller sized POBA or Selution study device) to establish distal flow reconstitution and adequate foot blush prior to treatment of the target tibial lesion.
• Inflow iliac and common femoral artery 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 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

You may not qualify if:

• 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 for a planned major amputation.
• Untreated flow-limiting inflow lesions
• Any previous surgery in the target vessel (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 uncorrected bleeding disorder
• Aneurysm located at the level of the SFA/popliteal artery
• Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
• Any condition which prevents patient 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Tjun Yip Tang

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Tze Tec Chong

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 1, 2020
• Study Start: September 9, 2020
• Primary Completion: December 20, 2021
• Study Completion: May 20, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)