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SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease (FUTURE-BTK)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04511247
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : January 20, 2022
Sponsor:
Information provided by (Responsible Party):
Concept Medical Inc.

Study Description
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Brief Summary:
This study aims to conduct a randomized, double blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of below the knee arterial disease.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Atherosclerosis Arterial Disease of Legs Device: MagicTouch PTA Sirolimus drug coated balloon Device: POBA balloon Not Applicable

Detailed Description:

The burden of limb loss as a result of peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by most vascular centers. Local drug delivery using drug coated balloons (DCB) during angioplasty for PAD can successfully deliver effective local tissue concentrations of anti-proliferative drugs to the lesions in the artery involved in the PAD. This offers the potential for sustained anti-restenotic efficacy.

Randomized trials have shown superiority of Paclitaxel DCBs over just plain-balloon angioplasty for treatment of PAD, and DCB is now considered the standard of care. However, a recent meta-analyses which showed increased mortality at two years in patients treated with paclitaxel DCBs have called into question the safety of paclitaxel based DCBs.

Alternative drugs for DCBs are therefore urgently needed and sirolimus offers an attractive alternative. Compared to Paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety. It has a high transfer rate to the vessel wall and has been shown to effectively inhibit neointimal hyperplasia in the porcine coronary model. In the coronary artery interventions, preliminary clinical studies using Sirolimus DCBs have also shown excellent procedural and 6 month patency.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible subjects will be randomised via a secure online system to a labelled device and to receive either Magic Touch sirolimus drug coated balloon in addition to standard balloon angioplasty or standard balloon angioplasty and placebo balloon.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FUTURE BTK: Randomized Controlled Trial of First SirolimUs CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment of Below The Knee Arterial Disease
Actual Study Start Date : August 15, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Sirolimus

Arms and Interventions
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Arm Intervention/treatment
Experimental: MagicTouch PTA sirolimus drug coated balloon (DCB)
MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty
 Device: MagicTouch PTA Sirolimus drug coated balloon
For participants randomised to MagicTouch PTA sirolimus DCB, following successful plain balloon angioplasty of the arterial lesion (defined as <30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), MagicTouch sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
Active Comparator: Placebo balloon angioplasty
Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)
 Device: POBA balloon
For participants randomised to the standard balloon angioplasty group, a placebo standard balloon which is identical to the SCB will also be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty


Outcome Measures
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Primary Outcome Measures :
  1. Primary patency at 6 months [ Time Frame: 6 months ]
    Primary patency rate at 6 months defined as proportion of subjects with duplex ultrasonography-derived peak systolic velocity ratio of ≤ 2.4 (in absence of target lesion revascularisation)


Secondary Outcome Measures :
  1. Device and procedure related deaths [ Time Frame: 1,6,12 and 24 Months ]
    Proportion of device and procedure related deaths

  2. All-cause death [ Time Frame: 1,6,12 and 24 Months ]
    Proportion of subjects died by any-cause

  3. Major target limb amputation [ Time Frame: 6,12 and 24 Months ]
    Proportion of subjects with major target limb amputation

  4. Target vessel thrombosis [ Time Frame: From day 0 to day 14 ]
    Proportion of subjects with target vessel thrombosis

  5. Proportion of subjects who experienced either death at 6 month or major target limb amputation at 6 month or target vessel thrombosis within 14 days. [ Time Frame: Day 0 to day 14, 6 Months ]
    Proportion of subjects who experienced either death at 6 month or major target limb amputation at 6 month or target vessel thrombosis within 14 days.

  6. Occurrence of adverse events (AEs), serious AEs and AEs related to device and procedure [ Time Frame: From Day 0 to 24 Months Follow-up ]
    Occurrence of adverse events (AEs), serious AEs and AEs related to device and Occurrence of adverse events (AEs), serious AEs and AEs related to device and procedure

  7. Procedural Success [ Time Frame: From Day 1 to discharge up to maximum of 30 days ]
    Proportion of subjects with procedural success during hospital stay

  8. Proportion of subjects who are free from clinically-driven Target Lesion Revascularization (TLR) [ Time Frame: 6,12 and 24 Months ]
    Proportion of subjects who are free from clinically-driven TLR

  9. Proportion of subjects who are free from clinically-driven Target Vessel Revascularization (TVR) [ Time Frame: 6,12 and 24 Months ]
    Proportion of subjects who are free from clinically-driven Target Vessel Revascularization (TVR)

  10. Primary patency [ Time Frame: 12 and 24 Months ]
    Primary patency rate at 12 and 24 months

  11. Restenosis [ Time Frame: 6, 12 and 24 Months ]
    Proportion of subjects with restenosis

  12. Subjects who are free from MAE [ Time Frame: 6 Months ]
    Proportion of subjects who are free from MAE

  13. Amputation-free survival [ Time Frame: 6, 12 and 24 Months ]
    Amputation-free survival

  14. Clinical Success [ Time Frame: 6, 12 and 24 Months ]
    Proportion of subjects with clinical Success at 6, 12 and 24 months, Clinical success is defined as Improvement in Rutherford classification compared to the pre-procedure Rutherford classification

  15. Device success [ Time Frame: Day 1 ]
    Proportion of subjects with device success at day 1

  16. Technical success [ Time Frame: Day 1 ]
    Proportion of subjects with technical success at day 1

  17. Wound assessment (if any) [ Time Frame: 1, 6, 12, 24 Months ]
    Wound assessment (if any)

  18. Toe Pressure or ABPI assessment [ Time Frame: 6, 12, 24 Months ]
    Toe Pressure or ABPI assessment


Other Outcome Measures:
  1. Health-related quality of life [ Time Frame: 12 and 24 months ]
    Mean change from baseline in EuroQol-5Dimensions (EQ-5D) health-related quality of life questionnaire score at 12 and 24 months. The score ranges from 0 to 1, and a higher score means a better outcome

  2. Walking impairment [ Time Frame: 12 and 24 months ]
    Mean change from baseline in walking impairment questionnaire score at 12 and 24 months. The score ranges from 0% to 100% and a higher score means a better outcome


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Age ≥ 21 years or minimum age

  2. Rutherford class 4 to 6 in the target limb

    Intraoperative Inclusion Criteria

  3. Single or sequential de novo or re-stenotic lesions (stenosis of > 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Below the knee arteries are tibioperoneal trunk, anterior tibial artery, posterior tibial artery and peroneal artery
  4. Inflow free from flow limiting lesions (<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (>50% stenosis) can be included if lesion had been treated successfully (<30% residual stenosis) before or during the index procedure.
  5. Target vessel has angiographically documented run off to the foot after treatment (ie. without significant stenosis)

Exclusion Criteria:

  1. Comorbid conditions limiting life expectancy ≤ 1 year
  2. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
  3. Subject is pregnant or planning to become pregnant during the course of the study
  4. Heel gangrene
  5. Prior bypass surgery of target vessel
  6. Planned amputation of the target limb
  7. Previously implanted stent in the target lesion
  8. Vulnerable or protected adults
  9. Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin

  10. Known allergy to sirolimus

    Intraoperative Exclusion Criteria

  11. 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).
  12. Target vessel has lesions extending beyond the ankle joint
  13. Failure to obtain <30% residual stenosis in a pre-existing lesion
  14. Lesions requiring retrograde access (SAFARI)
  15. Highly calcified lesions (Contiguous calcification on both sides of the lesion)
  16. Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)
Contacts and Locations
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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): NCT04511247


Contacts
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Contact: Edward Choke +65 69302164 edward.choke.t.c@singhealth.com.sg

Locations
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Korea, Republic of
Asan Medical Centre Not yet recruiting
Seoul, Korea, Republic of
Contact: Lee Seung Hwan, Dr.         
Singapore
Khoo Teck Puat Hospital Not yet recruiting
Singapore, Singapore
Contact: Leong Chuo Ren         
National University Hospital Recruiting
Singapore, Singapore
Contact: Jackie Ho         
Ng Teng Fong General Hospital Not yet recruiting
Singapore, Singapore
Contact: Vikram Vijayan         
Sengkang General Hospital Recruiting
Singapore, Singapore
Contact: Edward Choke         
Singapore General Hospital Recruiting
Singapore, Singapore
Contact: Tang Tjun Yip         
Tan Tock Seng Hospital Not yet recruiting
Singapore, Singapore
Contact: Pua Uei, Dr.         
Principal Investigator: Pua Uei, Dr.         
Taiwan
Far Eastern Memorial Hospital Not yet recruiting
New Taipei City, Taiwan
Contact: Chen Jer-Shen, Dr.         
Taipei Tzuchi Hospital Not yet recruiting
New Taipei City, Taiwan
Contact: Huang Hsuan-Li, Dr.         
National Taiwan University Hospital Not yet recruiting
Taipei City, Taiwan
Contact: Lee Jen-Kuang, Dr.         
Shin Kong Wu Ho-Su Memorial Hospital Not yet recruiting
Taipei City, Taiwan
Contact: Lin Chia-Hsun, Dr.         
Taipei Mackay Memorial Hospital Not yet recruiting
Taipei City, Taiwan
Contact: Tsai Cheng-Ting, Dr.         
Linkou Chang Gung Memorial Hospital Not yet recruiting
Taoyuan City, Taiwan
Contact: Chen Chun-Chi, Dr.         
Sponsors and Collaborators
Concept Medical Inc.
Investigators
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Principal Investigator: Edward Choke Sengkang General Hospital
More Information
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Publications:

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Responsible Party: Concept Medical Inc.
ClinicalTrials.gov Identifier: NCT04511247    
Other Study ID Numbers: FUTURE-BTK
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022

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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
DCB
PTA
Sirolimus
Additional relevant MeSH terms:
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Atherosclerosis
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Sirolimus
 Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs