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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368091
Recruitment Status : Active, not recruiting
First Posted : April 29, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Concept Medical Inc.

Brief 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). 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.

Condition or disease Intervention/treatment
Peripheral Artery Disease Atherosclerosis Device: Xtreme Touch - Neo sirolimus coated PTA balloon catheter

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : November 21, 2018
Actual Primary Completion Date : April 25, 2020
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Group/Cohort Intervention/treatment
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 Name: Magic Touch PTA - Sirolimus drug coated balloon




Primary Outcome Measures :
  1. Efficacy: Number of Patients with Primary patency [ Time Frame: 6 months ]
    Defined as by duplex ultrasonography-derived peak systolic velocity ratio of < 2.4

  2. Safety: Number of Patients with Freedom from Major Adverse Events (MAE) [ Time Frame: 6 months ]
    b. A composite of freedom from device- and procedure-related mortality, and major target limb amputation


Secondary Outcome Measures :
  1. Number of Patients with Freedom from clinically-driven TLR [ Time Frame: 6, 12, and 24 months ]
    Freedom From Clinically Driven Target Lesion Revascularization

  2. Number of Patients with Freedom from clinically-driven TVR [ Time Frame: 6 and 24 months ]
    Freedom From Clinically Driven Target Vessel Revascularization

  3. Number of Patients with Primary patency [ Time Frame: 12 and 24 months ]
    Percentage of subjects with duplex ultrasound Clinical Primary Patency

  4. 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

  5. Number of Patients with Amputation-free survival [ Time Frame: 6, 12 and 24 months ]
    Amputation-free survival of patients

  6. 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

  7. Number of Patients with Device success [ Time Frame: Day 0 ]
    Successful delivery, inflation, deflation, and retrieval of the Xtreme Touch - Neo balloon catheter.

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368091


Locations
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Singapore
Sengkang General Hospital
Singapore, Singapore, 544886
Sponsors and Collaborators
Concept Medical Inc.
Investigators
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Principal Investigator: Edward Choke Tieng Chek edward.choke.t.c@singhealth.com.sg
Publications:
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Responsible Party: Concept Medical Inc.
ClinicalTrials.gov Identifier: NCT04368091    
Other Study ID Numbers: XTOSI Pilot Study
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Concept Medical Inc.:
PAD
BTK
SFA
DCB
SCB
Additional relevant MeSH terms:
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Atherosclerosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs