Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
Study NCT ID:
NCT04534192
Status:
UNKNOWN
Last Update Posted:
2020-11-02
First Post:
2020-08-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TASC C and D Athero-occlusive Infra-inguinal Disease in Patients With Chronic Limb Threatening Limb Ischemia From SingaporE
Sponsor:
Singapore General Hospital
Organization:
Study Overview
Official Title:
Physician Initiated, Prospective, Non-randomized Single-centre, Single-arm Trial, Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TASC C and D Athero-occlusive Infra-inguinal Disease in Patients With Chronic Limb Threatening Limb Ischemia From SingaporE (PINNACLE)
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PINNACLE
Brief Summary:
The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions in patients with chronic limb threatening ischemia.
Detailed Description:
Pulsatile straight line blood flow to the foot is required to aid wound healing in the setting of chronic limb threatening ischaemia (CLTI). Patients with CLTI usually present with infra-popliteal arterial occlusions and endovascular therapies to restore blood flow are often preferred considering their inherently less invasive nature and because of multiple patient background comorbidities or absence of a suitable vein conduit in these patients. Below The Knee (BTK) plain balloon angioplasty (POBA) remains the only viable "standard of care" in the management of long "Real World" BTK Lesions. However tibial angioplasty is plagued by high rate of re-occlusion/stenosis because of barotrauma caused by the intra-arterial ballooning and subsequent development of neointimal hyperplasia. Devices coated with paclitaxel have been used successfully to limit restenosis by inhibiting the biologic pathway that leads to intimal hyperplasia. However, a recent formal systematic review and study-level meta-analysis of randomized controlled trials investigating treatment of the infra-popliteal arteries with paclitaxel-coated balloons compared with conventional balloon angioplasty for critical limb ischemia (CLI) was recently published showing amputation-free survival was significantly worse in use of paclitaxel coated balloons compared to plain angioplasty. Furthermore current poor patency seen in BTK angioplasty is likely contributed in part by small vessel size and poor luminal gain after standard semi-compliant POBA. Vessel Preparation and Optimising POBA with High Pressure, Non-Compliant balloons may help achieve Luminal Gain for rapid and sustained flow for wound healing. The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C \& D lesions in patients with chronic limb threatening ischemia.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: