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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 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-05-26

No results posted yet for this study

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

Interventions

DEVICE

SELUTION Sirolimus DCB

Suitable lesions will be treated with SELUTION Sirolimus DCB

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Tjun Yip Tang · Singapore General Hospital

  • Tze Tec Chong · Singapore General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2021-12-20
Completion
2022-05-20

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534257 on ClinicalTrials.gov