NCT04534257: PRISTINE

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

Status unknown NA Last updated 26 May 2022

What this trial tests

NA trial testing SELUTION Sirolimus DCB in Critical Lower Limb Ischemia in 75 participants. Status unknown.

Timeline

9 September 2020

Primary endpoint
20 December 2021

20 May 2022

Quick facts

Lead sponsor	Singapore General Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	9 September 2020
Primary completion	20 December 2021
Estimated completion	20 May 2022
Sites	1 location across Singapore

Drugs / interventions tested

• SELUTION Sirolimus DCB

Conditions studied

• Critical Lower Limb Ischemia — all drugs for Critical Lower Limb Ischemia →
• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →

Sponsor

Singapore General Hospital

Who can join

21 and older, any sex, with Critical Lower Limb Ischemia or Peripheral Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Utility of Sirolimus Eluting Balloons in the Setting of Chronic Limb Threatening Ischaemia in Asian Patients from Singapore - 12 Months Results of the PRISTINE Registry.
   Tang TY, Yap C, Chan SL, Soon SXY, et al · · 2024 · cited 6× · PMID 38898146 · DOI 10.1007/s00270-024-03756-3
2. Sirolimus coated balloons in peripheral arterial disease, what's next?
   Chan DYS, Wong JCL, Tang TY. · · 2025 · PMID 40115101 · DOI 10.21037/cdt-24-425