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

NCT04071782 | Completed

• 1 other identifier: CIRB 2019/2121
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Critical Limb Ischemia

Keywords

Angioplasty

Outcome Measures

Primary Outcomes (2)

• Clinical Primary Safety Endpoint

  Defined as freedom from Major Adverse Event (MAE) - A composite of freedom from device- and procedure-related mortality

  30 Days

• Performance Primary Endpoint

  Defined as 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

Secondary Outcomes (7)

• Primary Patency Rates

  12 Months

• Technical Success

  Intra-operative

• Freedom from clinically-driven TLR

  12 month

• Clinical success at follow-up

  12 months

• Wound healing

  6 months

Study Arms (1)

SELUTION Drug Coated Balloon

EXPERIMENTAL

Study participants will undergo lower limb angioplasty using SELUTION DCB, which is coated with sirolimus.

Device: Drug Coated Balloon

Interventions

Drug Coated Balloon DEVICE

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

Also known as: SELUTION

SELUTION Drug Coated Balloon

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of subject is \> 21 years old
• Patient has Critical Limb Ischemia, presenting a score from 4 to 6 following Rutherford Classification
• Patient is willing to comply with specified follow-up evaluations at the specified times
• 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 an MI within past 30 days
• Prior to enrolment, the guidewire has crossed the target lesion.
• De novo and post-PTA restenotic lesions located in the tibial arteries suitable for endovascular therapy
• Target lesion is located within the native tibial artery
• The length of the target lesion 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 predilated to \<30% residual stenosis using either POBA or high pressure POBA. No other adjunctive devices have been used to prepare the lesion (example - scoring balloons, rotablator, atherectomy device)
• Target vessel diameter is \>1.5mm and \<4.5mm below the knee
• Either one or two different tibial arteries may be treated. Lesions in the treated segment may be continuous or may have gaps present between stenoses and occlusions.
• Any tibial vessel intervened on must have distal reconstitution above the ankle
• Inflow iliac, SFA and popliteal lesions can be treated during the same procedure using standard angioplasty and/or approved devices. These inflow lesions must be treated first prior to consideration of treatment of the BTK lesions. The patient can be enrolled if the inflow lesions are treated with good angiographic results (must have \<30% residual stenosis and no evidence of 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 refusing treatment
• Patient is permanently wheel-chair bound or bedridden
• Presence of a stent in the target lesion that was placed during a previous procedure
• The intervention is being performed in preparation of a planned amputation
• Untreated flow-limiting inflow lesions
• Any previous surgery in the target vessels (including prior ipsilateral crural bypass)
• Previous bypass surgery in the same limb
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
• Perforation at the angioplasty site evidenced by extravasation of contrast medium.
• Untreatable lesion located at the distal outflow arteries
• Patients with uncorrectable bleeding disorders
• Aneurysm located at the level of the SFA/popliteal artery
• Non-artherosclerotic disease resulting in occlusion
• Any condition which prevents patients from complying with the study protocol or if patient has a life expectancy of \< 1 year.
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; 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

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Tze Tec Chong

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: October 8, 2019
• Primary Completion: July 30, 2020
• Study Completion: January 30, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)