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Peripheral Artery DiseaseXTOSINCT04368091

Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA)- Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease

An observational study of Peripheral Artery Disease and Atherosclerosis, run by Concept Medical Inc. 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

This study postulates that the application of Sirolimus, an anti-proliferative agent that inhibits neointimal hyperplasia, via Sirolimus coated balloon (SCB) will be safe and will result in better arterial patency in infrainguinal peripheral arterial disease (PAD). Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Peripheral Artery Disease, Atherosclerosis
What is being tested?
Xtreme Touch - Neo sirolimus coated PTA balloon catheter
Type of treatment
Medical device
How many people
50 participants
Where
1 siteSingapore
Study dates
21 Nov 2018to 30 Dec 2021
Phase
Observational
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

Study population: Subjects from an all-comers patient population with all subjects requiring infrainguinal revascularization with the Xtreme Touch - Neo.

Who may be able to join

  • Age ≥ 21 years or minimum age
  • Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable
  • Lesion(s) in the infrainguinal arteries between 3 to 6mm which are suitable for endovascular treatment treated with the Xtreme Touch - Neo sirolimus PTA balloon catheter. For below the knee (BTK) arteries, lesions located in the proximal 200mm of the artery.

Who cannot join

  • Life expectancy ≤ 1 year
  • Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet
  • Subject is pregnant or planning to become pregnant during the course of the study
  • Failure to achieve less than 30% residual stenosis in pre-existing lesion after plain balloon angioplasty
  • Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Sengkang General Hospital

    Singapore, 544886

Other trials in Singapore

About this study

Official title: XTOSI Pilot Study: Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA) - Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease

This study postulates that the application of Sirolimus, an anti-proliferative agent that inhibits neointimal hyperplasia, via Sirolimus coated balloon (SCB) will be safe and will result in better arterial patency in infrainguinal peripheral arterial disease (PAD). The aim is to evaluate the efficacy (12 month freedom from clinically driven target lesion revascularisation) and safety (freedom from major adverse events) of sirolimus coated balloons in the treatment of infrainguinal PAD.

Read the detailed description

It is imperative to have effective treatment strategies for PAD which can maintain the patency of arteries. The current standard of care for PAD is angioplasty which includes usage of drug coated balloons (DCB). Paclitaxel is the only anti-proliferative drug available in all currently available DCB technology. Sirolimus is another highly effective anti-proliferative drug of immense potential as demonstrated by superior results in Sirolimus drug eluting stents in coronary disease. The physical properties of Sirolimus have made it challenging for it to be similarly applied to DCB technology and it is only due to recent advances in nanotechnology that it is now possible to develop Sirolimus coated balloons (SCB), which is the study device used in this study. The study device allows delivery and deposition of sirolimus to the arterial wall. By applying this agent into lesions in peripheral arterial disease, this study aim to effectively reduce neointimal hyperplasia, and therefore prolong the patency of the artery and improve our limb salvage rates for PAD and CLI patients. Subjects will be followed up in the clinic at 6 month, 12 month, and 24 month post-intervention to assess primary and secondary outcome of safety and efficacy.

Being tested
Xtreme Touch - Neo sirolimus coated PTA balloon catheter
Keywords
PAD, BTK, SFA, DCB, SCB
Medical subject headings
Peripheral Arterial Disease, Atherosclerosis

What participants receive

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

  • Xtreme Touch - Neo sirolimus coated PTA balloon catheterDevice

    Also called Magic Touch PTA - Sirolimus drug coated balloon

    The Xtreme Touch (Magic Touch PTA) - Neo Sirolimus PTA Balloon Catheter is the world's first sirolimus coated PTA balloon. The purpose of the X-TOSI all-comers registry is to collect short and long-term clinical performance data on the Xtreme Touch (Magic Touch PTA) -Neo sirolimus PTA balloon catheter in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in real world daily clinical practice.

Study groups in NCT04368091
Study groupRoleWhat they receive
All-comers, real-world registrySubjects requiring infrainguinal revascularization with the Xtreme Touch - Neo (Magic Touch PTA)
Receives: Device: Xtreme Touch - Neo sirolimus coated PTA balloon catheter

What is being measured

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

  1. Efficacy: Number of Patients with Primary patency

    Defined as by duplex ultrasonography-derived peak systolic velocity ratio of < = 2.4

    Measured: 6 months

  2. Safety: Number of Patients with Freedom from Major Adverse Events (MAE) defined as composite of

    1. freedom from device- and procedure-related mortality, and major target limb amputation through to 30 days, and
    2. Freedom from clinically driven target lesion revascularization (TLR) within 6 months post-index procedure.

    Measured: 6 months

Secondary outcomes (9)

  1. Number of Patients with Freedom from clinically-driven TLR

    Freedom From Clinically Driven Target Lesion Revascularization

    Measured: 6, 12, and 24 months

  2. Number of Patients with Freedom from clinically-driven TVR

    Freedom From Clinically Driven Target Vessel Revascularization

    Measured: 6 and 24 months

  3. Number of Patients with Primary patency

    Percentage of subjects with duplex ultrasound Clinical Primary Patency

    Measured: 12 and 24 months

  4. Number of Patients with Freedom from MAE

    1. A composite of freedom from device- and procedure-related mortality, and major target limb amputation

    Measured: 12 and 24 months

  5. Number of Patients with Amputation-free survival

    Amputation-free survival of patients

    Measured: 6, 12 and 24 months

  6. Number of Patients with Improvement in Rutherford classification

    Improvement in Rutherford classification compared to the pre-procedure Rutherford classification

    Measured: 6, 12 and 24 months

  7. Number of Patients with Device success

    Successful delivery, inflation, deflation, and retrieval of the Xtreme Touch - Neo balloon catheter.

    Measured: Day 0

  8. Number of Patients with Technical success

    Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation

    Measured: Day 0

  9. Number of Patients with Procedural success

    Participants will be followed for the duration of hospital stay, an expected average of 1-2 days

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days

Timeline

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

  1. First posted29 Apr 2020
  2. Study start21 Nov 2018
  3. Primary completion25 Apr 2020
  4. Study completion30 Dec 2021

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04368091
Sponsor's protocol ID
XTOSI Pilot Study
Acronym
XTOSI
Status last verified
Mar 2022
First submitted
27 Apr 2020
Last updated
9 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Giacoppo D, Cassese S, Harada Y, Colleran R, Michel J, Fusaro M, Kastrati A, Byrne RA. Drug-Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials. JACC Cardiovasc Interv. 2016 Aug 22;9(16):1731-42. doi: 10.1016/j.jcin.2016.06.008.

    PubMed 27539695

  • Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Bohm M, Speck U, Scheller B. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543. doi: 10.1161/CIRCINTERVENTIONS.115.003543.

    PubMed 27069105

  • Verheye S, Vrolix M, Kumsars I, Erglis A, Sondore D, Agostoni P, Cornelis K, Janssens L, Maeng M, Slagboom T, Amoroso G, Jensen LO, Granada JF, Stella P. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2029-2037. doi: 10.1016/j.jcin.2017.06.021. Epub 2017 Sep 27.

    PubMed 28964764

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Artery Disease and Atherosclerosis, run by Concept Medical Inc. 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 3 inclusion and 5 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 9 Mar 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?

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?

Efficacy: Number of Patients with Primary patency (time frame: 6 months). 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 NCT04368091, which also lists 3 linked publications.

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 9 Mar 2022.

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