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 (XTOSI)

March 7, 2022 updated by: Concept Medical Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 544886
        • Sengkang General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All-comers, real-world registry
Subjects requiring infrainguinal revascularization with the Xtreme Touch - Neo (Magic Touch PTA)
Device: Xtreme Touch - Neo sirolimus coated PTA balloon catheter
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.
Other Names:
  • Magic Touch PTA - Sirolimus drug coated balloon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy: Number of Patients with Primary patency
Time Frame: 6 months
Defined as by duplex ultrasonography-derived peak systolic velocity ratio of < = 2.4
6 months
Safety: Number of Patients with Freedom from Major Adverse Events (MAE) defined as composite of
Time Frame: 6 months
  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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Patients with Freedom from clinically-driven TLR
Time Frame: 6, 12, and 24 months
Freedom From Clinically Driven Target Lesion Revascularization
6, 12, and 24 months
Number of Patients with Freedom from clinically-driven TVR
Time Frame: 6 and 24 months
Freedom From Clinically Driven Target Vessel Revascularization
6 and 24 months
Number of Patients with Primary patency
Time Frame: 12 and 24 months
Percentage of subjects with duplex ultrasound Clinical Primary Patency
12 and 24 months
Number of Patients with Freedom from MAE
Time Frame: 12 and 24 months
b. A composite of freedom from device- and procedure-related mortality, and major target limb amputation
12 and 24 months
Number of Patients with Amputation-free survival
Time Frame: 6, 12 and 24 months
Amputation-free survival of patients
6, 12 and 24 months
Number of Patients with Improvement in Rutherford classification
Time Frame: 6, 12 and 24 months
Improvement in Rutherford classification compared to the pre-procedure Rutherford classification
6, 12 and 24 months
Number of Patients with Device success
Time Frame: Day 0
Successful delivery, inflation, deflation, and retrieval of the Xtreme Touch - Neo balloon catheter.
Day 0
Number of Patients with Technical success
Time Frame: Day 0
Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation
Day 0
Number of Patients with Procedural success
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days
Participants will be followed for the duration of hospital stay, an expected average of 1-2 days
Participants will be followed for the duration of hospital stay, an expected average of 1-2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Concept Medical Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward Choke Tieng Chek, edward.choke.t.c@singhealth.com.sg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XTOSI Pilot Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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