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Sirolimus Coated Angioplasty Versus Plain Balloon Angioplasty (IMPRESSION)

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ClinicalTrials.gov Identifier: NCT04409912
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : August 6, 2021
Sponsor:
Collaborators:
National University Hospital, Singapore
Sengkang General Hospital
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

A functioning dialysis access is critical to the delivery of hemodialysis therapy in patients with End Stage Renal Disease. Stenosis secondary to neo-intimal hyperplasia frequently occur within the dialysis access, resulting in dysfunction. Conventional balloon angioplasty is the current standard of care for treatment of stenosis but is associated with high rate of recurrence. Paclitaxel coated balloon has been shown to be superior to conventional balloon angioplasty in dialysis access interventions but recent meta-analysis has shown an increase in mortality when paclitaxel coated balloon and stents are used in lower limb angioplasty. Sirolimus coated angioplasty balloon are second generation drug coated balloon that have been shown to be effective in coronary artery interventions. Sirolimus is cytostatic in nature with good safety profile. In our pilot study, sirolimus coated balloon has been shown to be safe and effective in the salvaged of thrombosed arteriovenous graft. Therefore, the investigators are conducting a double-blinded, multi-center randomised control trial to compare the 6 month patency of arteriovenous fistula after intervention with sirolimus coated balloon versus conventional balloon angioplasty.

The investigators hypothesise that the addition of SCB after successful balloon angioplasty with conventional plain balloon is superior to conventional plain balloon angioplasty alone with decreased restenosis of the treated lesion, improved access circuit and treated lesion patency, and decreased number of interventions needed to maintain patency.


Condition or disease Intervention/treatment Phase
End Stage Renal Failure on Dialysis Arteriovenous Graft Occlusion Device: Sirolimus coated balloon Device: Plain balloon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly allocated in a 1:1 ratio into either the treatment (SCB) arm or control (PB) arm. As above-elbow AVFs generally have larger vessel size and better outcomes compared to below-elbow AVFs, randomisation will be stratified by location of AVF (above vs below elbow) to ensure a more even distribution of AVF by location between both groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Dialysis centre staff and procedurist performing the intervention will also be masked
Primary Purpose: Treatment
Official Title: SIroliMus Coated angioPlasty Versus Plain Balloon Angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION)
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: Sirolimus coated balloon
The trial product is MagicTouch sirolimus drug coated balloon (Concept Medical). Sirolimus will be transferred from the balloon to the vessel wall by inflating the sirolimus coated balloons at 2 minutes at rated burst pressure (typically 12 to 14ATM). All the lesions within the dialysis circuit with sirolimus coated balloon.
Device: Sirolimus coated balloon

Sirolimus has a high transfer rate to the vessel wall and effectively inhibit neointimal hyperplasia in the porcine coronary model. In coronary artery interventions, preliminary clinical studies using sirolimus coated balloon have shown excellent procedural and 6 month patency. The effectiveness of sirolimus coated balloon in patients with dialysis access dysfunction has been shown in a small pilot study in the salvage of thrombosed arteriovenous graft.

When compared to Paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety.


Placebo Comparator: Plain balloon
The plain balloon or placebo will not be coated. The plain balloon will be inflated at 2 minutes at rated burst pressure (typically 12 to 14 ATM). Plain balloon will be applied to all the narrowed segment of the dialysis circuit
Device: Plain balloon
Plain balloon angioplasty is the current standard therapy to treat stenosis in dialysis access. However, the mid and long term patency of plain balloon angioplasty in patients with end stage renal disease is poor. The average primary patency is around 40 to 50 percent at 1 year and multiple repeated angioplasty is required to maintain the patency of the vascular access.




Primary Outcome Measures :
  1. Primary patency of the AVF at 6 months [ Time Frame: 6 months ]
    This is measured by the percentage of patients whose AVF remain patent at 6 months after the procedure


Secondary Outcome Measures :
  1. Time taken to the next intervention [ Time Frame: Through study completion, an average of 1 year ]
    The number of months from procedure to the next interventions. This will be track until study completion.

  2. Treated lesion percent stenosis at 6 and 12 month ultrasound [ Time Frame: 6 and 12 months ]
    Defined as percent stenosis relative to adjacent reference vessel, [1 - (minimum lesion diameter / reference vessel diameter)] x 100)

  3. Treated lesion re-stenosis rate at 6 months [ Time Frame: 6 months ]
    Defined as incidence of stenosis > 50% diameter of adjacent reference vessel segment

  4. Number of repeat interventions to treated lesion at 6 and 12 months [ Time Frame: 6 and 12 months ]
    How many repeat interventions to treated lesion at 6 and 12 months

  5. Number of repeat interventions to maintain access circuit (including interventions to treated lesion) at 6 and 12 months [ Time Frame: 6 and 12 months ]
    How many repeat interventions to maintain access circuit (including interventions to treated lesion) at 6 and 12 months

  6. Treated lesion revascularisation free interval [ Time Frame: anytime within 12 months study participation ]
    Defined as the interval from intervention to repeat clinically driven target lesion intervention

  7. De nova stenosis detected on ultrasound scan at 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months ]
    Presence of De nova stenosis detected on ultrasound scan at 3, 6 and 12 months

  8. Post intervention treated lesion patency at 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months ]
    Percentage of patients whose treated stenosis remains patent at 3, 6, and 12 months after the procedure. This is determined by the use of ultrasound imaging or angiogram or clinical examination.

  9. Post-intervention primary patency at 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months ]
    Percentage of patients whose AVF remains patent and does not require any further interventions at 3, 6, and 12 months after the procedure. This is determined by the use of ultrasound imaging or angiogram or clinical examination.

  10. Post-intervention assisted primary patency at 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months ]
    Percentage of patients whose AVF requires additional interventions to remains patent at 3, 6, and 12 months after the procedure. This is determined by clinical history during the study period

  11. Post-intervention secondary patency at 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months ]
    Percentage of patients whose AVF has thrombosed and required additional procedure to restore flow at 3, 6, and 12 months after the procedure. This is determined by clinical history during the study period.

  12. Complication rates at 1, 3, 6 and 12 months [ Time Frame: 1, 3 6 and 12 months ]
    Complication rates at 1, 3, 6 and 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 21 to 85 years
  2. Patient who requires balloon angioplasty for dysfunction arteriovenous fistula
  3. Matured AVF, defined as being in use for at least 1 month prior to angioplasty
  4. 4. Successful angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA) based on visual assessment of the operator and restoration of thrill in the AVF on clinical examination. (For concurrent asymptomatic or angiographically not significant central vein stenosis, patients can be included if no treatment is required.)

Exclusion Criteria:

  1. Patient unable to provide informed consent
  2. Thrombosed or partially thrombosed AVF
  3. Presence of symptomatic or angiographically significant central vein stenosis who require treatment, with more than 30% residual stenosis post angioplasty
  4. Patients who had underwent stent placement within the AVF circuit
  5. Patient who are currently enrolled in other drug eluting balloon trials
  6. Sepsis or active infection
  7. Recent intracranial bleed or gastrointestinal bleed within the past 12 months
  8. Allergy to iodinated contrast media, anti-platelet drugs, heparin or sirolimus
  9. Pregnancy

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): NCT04409912


Contacts
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Contact: Chieh Suai Tan, MD +6581231127 tan.chieh.suai@singhealth.com.sg

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Jackie Pei Ho, MD       surhp@nus.edu.sg   
Principal Investigator: Jackie Pei Ho, MD         
Sub-Investigator: Rajesh Babu Dharmaraj, MD         
Sub-Investigator: Jun Jie Ng, MD         
Sub-Investigator: Julian Chi Leung Wong, MD         
Sub-Investigator: Anil Gopinathan, MD         
Sub-Investigator: Stanley Eu Kuang Loh, MD         
Sub-Investigator: Shao Jin Ong, MD         
Sub-Investigator: Gary Yoong, MD         
Sub-Investigator: Xinquan Chen         
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Chieh Suai Tan, MD       tan.chieh.suai@singhealth.com.sg   
Principal Investigator: Chieh Suai Tan, MD         
Sub-Investigator: Ru Yu Tan, MD         
Sub-Investigator: Suh Chien Pang, MD         
Sub-Investigator: Alvin Ren Kwang Tng, MD         
Sub-Investigator: Kiang Hiong Tay, MD         
Sub-Investigator: Luke Han Wei Toh, MD         
Sub-Investigator: Shaun Xavier Ju Min Chan, MD         
Sub-Investigator: Jasmine Ming Er Chua, MD         
Sub-Investigator: Apoorva Gogna, MD         
Sub-Investigator: Farah Gillan Irani, MD         
Sub-Investigator: Pradesh Kumar Kutty Krishnan, MD         
Sub-Investigator: Kristen Alexa Lee, MD         
Sub-Investigator: Sum Leong, MD         
Sub-Investigator: Richard Hoau Gong Lo, MD         
Sub-Investigator: Ankur Patel, MD         
Sub-Investigator: Bien Soo Tan, MD         
Sub-Investigator: Chow Wei Too, MD         
Sub-Investigator: Kun Da Zhuang, MD         
Sub-Investigator: Tze Tec Chong, MD         
Sub-Investigator: Siew Ping Chng, MD         
Sub-Investigator: Tjun Yip Tang, MD         
Sub-Investigator: Hsien Ts'ung Tay, MD         
Sub-Investigator: Hao Yun Yap, MD         
Sub-Investigator: Chee Wooi Tan, MD         
Sub-Investigator: Nanda Kumar Karaddi Venkatanarasimha, MD         
Sub-Investigator: Sivanathan Chandramohan, MD         
Sub-Investigator: Sonam Tashi, MD         
Sub-Investigator: Alfred Bingchao Tan, MD         
Sub-Investigator: Alexander Sheng Ming Tan, MD         
Sub-Investigator: Mark Qi Wei Wang, MD         
Sengkang General Hospital Recruiting
Singapore, Singapore, 544886
Contact: Edward Tieng Chek Choke, MD       edward.choke.t.c@singhealth.com.sg   
Principal Investigator: Edward Tieng Chek Choke, MD         
Sub-Investigator: Jia Sheng Tay, MD         
Sponsors and Collaborators
Singapore General Hospital
National University Hospital, Singapore
Sengkang General Hospital
Investigators
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Principal Investigator: Chieh Suai Tan, MD Singapore General Hospital
Publications:
Office NRoD: Trends in Chronic Kidney Failure Stage 5 in Singapore 2012 / 2013. In.
Updated CIRSE Position Statement on the use of paclitaxel-coated balloons and stents in peripheral arterial disease.https://www.cirse.org/research/current-updates/
UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers. https://www.fda.gov/medical-devices/letters-health-care-providers/update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT04409912    
Other Study ID Numbers: 2019/2896
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs