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Critical Lower Limb IschemiaPRISTINENCT04534257

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

A study testing SELUTION Sirolimus DCB in people with Critical Lower Limb Ischemia and Peripheral Artery Disease, run by Singapore General Hospital at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
SELUTION Sirolimus DCB
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSingapore
Study dates
9 Sep 2020to 20 May 2022
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 years and older
  • 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 understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
  • Patient is willing to comply with specified follow-up evaluations at the specified times
  • 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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  • Angiographic Inclusion Criteria
  • De novo and post-PTA re-stenotic lesions located in the SFA, popliteal and/or tibial arteries suitable for endovascular therapy
  • The target lesion is located within the SFA, popliteal and/or tibial and infra-malleolar arteries
  • The length of the target lesion is > 50mm 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 pre-dilated to <30% residual stenosis using any combination of POBA, high pressure POBA, scoring balloon, or rotablator.
  • Target vessel diameter visually estimated is >1.5mm and <7 mm below the groin to the foot
  • Lesions in the treated segment may be continuous or may have gaps present between stenoses and occlusions
  • The target lesion has both patent inflow and at least one patent outflow tract extending to below the ankle. If required, the vessels of the ankle and foot should be treated with pre-dilatation and deployment of an appropriated sized balloon (i.e. smaller sized POBA or Selution study device) to establish distal flow reconstitution and adequate foot blush prior to treatment of the target tibial lesion.
  • Inflow iliac and common femoral artery lesions can be treated during the same procedure using standard angioplasty and/or approved device. 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 for a planned major amputation.
  • Untreated flow-limiting inflow lesions
  • Any previous surgery in the target vessel (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 uncorrected bleeding disorder
  • 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 <1 year.
  • Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
  • Septicaemia or bacteraemia
  • 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 acute limb ischaemia within the previous 1 month
  • Use of, 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 immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampycin) within 90 days following the procedure.
  • Subject has tested positive for Dengue, Covid19, Ebola, SARS, or MERS. If subject becomes infected during the course of the study, the resulting outcomes data will be recorded but will not be included the analysable results from the study.
  • 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
  • Any patient who has received a paclitaxel coated DCB within 30 days prior to the index procedure. If the patient receives a paclitaxel DCB in a peripheral vessel during the index procedure, that patients clinical outcomes shall not be included in calculation of the primary or secondary endpoints of the 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, 169856

Other trials in Singapore

About this study

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

Being tested
SELUTION Sirolimus DCB
Keywords
Drug-eluting balloon, Sirolimus
Medical subject headings
Peripheral Arterial Disease

What participants receive

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

  • SELUTION Sirolimus DCBDevice

    Suitable lesions will be treated with SELUTION Sirolimus DCB

Study groups in NCT04534257
Study groupRoleWhat they receive
Angioplasty with SELUTION Sirolimus DCBExperimentalSubjects with infra-inguinal occlusive lesions will be treated with SELUTION Sirolimus DCB
Receives: Device: SELUTION Sirolimus DCB

What is being measured

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

  1. Freedom from Major Adverse Events

    Composite of freedom from device- and procedure-related mortality

    Measured: 30 days post-index procedure

  2. Freedom from clinically driven target lesion revascularization

    Any re-intervention performed for more than 50% diameter stenosis at target lesion after documentation of recurrent or unresolved and continuing clinical symptoms

    Measured: 6 months post-index procedure

Secondary outcomes (7)

  1. Primary patency

    Absence of hemodynamically significant stenosis on duplex ultrasound at target lesion and without target lesion revascularization between time of procedure and the given follow-up

    Measured: 6 and 12 months post-index procedure

  2. Technical Success

    Ability to cross and dilate the lesions and achieve residual angiographic stenos no greater than 30%

    Measured: Immediately post-op

  3. Freedom from clinically-drive target lesion revascularization

    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 respective time points

    Measured: 12 month post-index procedure

  4. Clinical success at follow-up

    Improvement of Rutherford classification at all follow-up time points of one class or more as compared to the pre-procedure Rutherford classification

    Measured: 6 and 12 months post index procedure

  5. Wound healing

    Closure of primary wound by more than 70%

    Measured: 6 months post-index procedure

  6. Freedom from major target limb amputation

    Measured: 6 and 12 months post-index procedure

  7. Freedom from Serious Adverse Events

    Measured: 1 year post-index procedure

Timeline

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

  1. First posted1 Sep 2020
  2. Study start9 Sep 2020
  3. Primary completion20 Dec 2021
  4. Study completion20 May 2022 (estimated)

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
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04534257
Sponsor's protocol ID
2020/2605
Acronym
PRISTINE
Status last verified
May 2022
First submitted
26 Aug 2020
Last updated
26 May 2022
Results posted
No
Data monitoring committee
Yes
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 SELUTION Sirolimus DCB in people with Critical Lower Limb Ischemia and Peripheral Artery Disease, 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 16 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 26 May 2022. 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?

Results are not available in the source record.

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?

Freedom from Major Adverse Events (time frame: 30 days post-index procedure). 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 NCT04534257.

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 26 May 2022.

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