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Critical Limb IschemiaPRESTIGENCT04071782

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

A study testing Drug Coated Balloon in people with Critical Limb Ischemia, run by Singapore General Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Critical Limb Ischemia
What is being tested?
Drug Coated Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteSingapore
Study dates
8 Oct 2019to 30 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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)
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  • 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
  • Septicemia or bacteremia
  • Patient has undrained pus or spreading wet gangrene in the foot that is not controlled at the time of revascularization procedure
  • Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb)
  • Episode of thrombectomy, cutting balloon, lithotripsy, atherectomy or laser devices during procedure
  • Any patient considered to be hemodynamically unstable at onset of procedure
  • Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
  • The patient is currently breast-feeding, pregnant or intends to become pregnant
  • Subject receiving immunosuppression therapy, or has known serious immunosuppression therapy, or has known serious immunosuppressive disease (e.g. human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy. The patient should also not receive inhibitors of CYP3A (such as Itraconazole, Erythromycin) or inducer of CYP3A (such as Rifampin) within 90 days following procedure
  • Patient is participating in another research study of a device, medication, biologic, or other agent within 30 days which could in the opinion of the investigator affect the results of this study
  • Patients with lesion to be treated with residual stenosis after POBA of >30%

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

About this study

Official title: 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

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)

Read the 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.

Being tested
Drug Coated Balloon
Keywords
Angioplasty
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug Coated BalloonDevice

    Also called SELUTION

    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

Study groups in NCT04071782
Study groupRoleWhat they receive
SELUTION Drug Coated BalloonExperimentalStudy participants will undergo lower limb angioplasty using SELUTION DCB, which is coated with sirolimus.
Receives: Device: Drug Coated Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Primary Safety Endpoint

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

    Measured: 30 Days

  2. 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

    Measured: 6 Months

Secondary outcomes (7)

  1. Primary Patency Rates

    Primary patency defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.5) at the target lesion and without target lesion revascularization within the time of procedure and the given follow-up.

    Measured: 12 Months

  2. Technical Success

    Defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%

    Measured: Intra-operative

  3. Freedom from clinically-driven TLR

    Defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points

    Measured: 12 month

  4. Clinical success at follow-up

    Defined as an improvement of Rutherford Classification at all follow-up time points of once class or more as compared to the pre-procedure Rutherford Classification

    Measured: 12 months

  5. Wound healing

    Defined as closure of primary wound by more than 70% at 6 months or complete healing of primary closed wounds

    Measured: 6 months

  6. Freedom from Major Target Limb Amputation

    Measured: 12 months

  7. Freedom from Severe Adverse Events

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start8 Oct 2019
  3. Primary completion30 Jul 2020
  4. Study completion30 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04071782
Sponsor's protocol ID
CIRB 2019/2121
Acronym
PRESTIGE
Status last verified
Oct 2021
First submitted
26 Aug 2019
Last updated
21 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Drug Coated Balloon in people with Critical Limb Ischemia, run by Singapore General Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Primary Safety Endpoint (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04071782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.

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