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

NCT04534192 | Unknown DMC

• 1 other identifier: 2020/2425
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Limb Ischemia; Peripheral Artery Disease

Keywords

non-compliant high pressure balloon; JADE

Outcome Measures

Primary Outcomes (2)

• Freedom from Major Adverse Events

  A composite of freedom from device- and procedure-related mortality through 30 days

  30 days post-index procedure

• Performance Primary Endpoint

  Freedom from clinically driven target lesion revascularization (TLR) within 6 months post-index procedure. (Clinically driven TLR is defined as any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent or unresolved and continuing clinical symptoms of the patient.)

  6 months post-index procedure

Secondary Outcomes (8)

• Primary patency rate

  6- and 12-month post-index procedure

• Technical success

  Immediately post-op

• Freedom from clinically-driven TLR

  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)

JADE balloon

EXPERIMENTAL

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.

Device: JADE Balloon

Interventions

JADE Balloon DEVICE

Suitable TASC C and D lesions will be treated with non-compliant high pressure JADE balloon.

JADE balloon

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of subject is \> 40 years old. Patient covered by MediShield insurance as provided by Singapore government.
• Patient has critical limb ischemia, presenting a score from 4 to 6 following the Rutherford classification
• Patients must agree to return for all required post-index procedure follow-up visits.
• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient has a projected life expectancy of at least 12 months and has not suffered a myocardial infarction within past 30 days
• De novo and post-PTA re-stenotic lesions located in the superficial femoral, popliteal and tibial arteries suitable for endovascular therapy
• The target lesion is located within the native SFA/popliteal/tibial artery
• The length of the target lesion(s) is \> 100mm 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 no other adjunctive devices have been used to prepare the lesion (example scoring balloon, rotablator, atherectomy device)
• Target vessel diameter visually estimated is \>1.5mm and \< 6.5mm below the groin
• Prior to enrolment, the guidewire has crossed the target lesion
• Lesions in the treated segment may be continuous or may have gaps present between stenoses and occlusions
• Inflow iliac, common femoral artery lesions can be treated during the same procedure using standard angioplasty and/or approved device/open surgery. These inflow lesions must be treated first prior to consideration of treatment of the distal lying lesions. The patient can be enrolled if the inflow lesions are treated with good 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 is permanently wheel-chair bound or bedridden
• Presence of a stent in the target lesion(s) that was placed during a previous procedure
• The intervention is being performed in preparation for a planned 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 with a history of Myocardial Infarction (MI), thrombolysis or angina within 30 days prior-index procedure.
• Patients with a history of major disabling stroke within 3 months prior index procedure.
• Patients with any type of previous or planned surgical or interventional procedure within 15 days prior- and/or within 30 days post-index procedure.
• Untreatable lesion located at the distal outflow arteries
• Patients with uncorrected bleeding disorders
• 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 \<1yr.
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb

Sponsors & Collaborators

• Singapore General Hospital: lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Tjun Yip Tang, MD

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charyl Yap, BSc

CONTACT

65767986; Charyl.yap.j.q@singhealth.com.sg

Shereen Soon, BSc

CONTACT

+6597336263; shereensoon@outlook.com

Study Design

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

Model Details: Non-randomized, single arm

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 1, 2020
• Study Start: August 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: August 1, 2022
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)