NCT04071782

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

Physician Initiated, Prospective, Non-Randomized Single-Center Trial, 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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed 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.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
DEVICE	Drug Coated Balloon	SELUTION DCB will be used during lower limb angioplasty for treatment of lesions that are TASC C and D, in patients with Critical Limb Ischemia

Timeline

• Start date: 2019-10-08
• Primary completion: 2020-07-30
• Completion: 2021-01-30
• First posted: 2019-08-28
• Last updated: 2021-10-21

Locations

1 site across 1 country: Singapore