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Sirolimus Coated Angioplasty Balloon in the Salvage of Thrombosed Arteriovenous Graft

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ClinicalTrials.gov Identifier: NCT03666208
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

End stage renal disease is on increasing trend. Haemodialysis is the main dialysis modality among these patients which accounts for the incidence of 81.3% in 2015 based on data from Singapore renal registry. Thus, A functioning dialysis vascular access (either arteriovenous Fistula or graft) is critical to the delivery of life-saving haemodialysis treatment to these patients.

The main focus in our study is thrombosed (blocked) AVG as it has higher thrombosis rate and poorer patency rate. Conventionally, to restore the function of the dialysis access, the thrombus (clot) will be lysed with the use of lytic agent; followed by treatment of the underlying stenosis (narrowing) with plain balloon angioplasty (dilatation). However narrowing often recur and multiple repeated angioplasty procedures are needed keep the AVG flowing to prevent clots formation.

Recently developed balloons called drug eluting balloons, are coated with medications to prevent the narrowing from recurring after angioplasty. With these drug balloons, the AVG can potentially continue to have good flow for a longer period of time, hence, decreasing the chance of clotting. A newer generation of drug-eluting balloon, called sirolimus coated balloon, are coated with a medicine called sirolimus. It has been successfully used in the treatment of narrowing of vessels in the leg and heart and it were superior than conventional paclitaxel coated balloon angioplasty.

We hypothesis that sirolimus coated balloon is superior to conventional plain balloon angioplasty with decreased re-stenosis of target lesion, improved access circuit and target 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This is a phase 2, pilot clinical trial to investigate the effect of SCB on thrombosed AVG. Specifically, we are focusing on AVG as they have a higher thrombosis rate than AVF and the patency rate even after successful thrombolysis is much lower than AVF. As neointimal hyperplasia is the predominant cause for stenosis at the graft vein junction, treatment with Sirolimus will intuitively delay the recurrence of neo-intimal hyperplasia and result in better patency of the AVG after successful thrombolysis.

Patients with ESRD presenting with a thrombosed AVG between June 2018 and December 2018 will be screened for suitability. Eligible patients of at least 21 years of age will be offered participation. The potential benefits and risks of SCB will be explained and informed consent obtained from participants. A total of 20 patients will be recruited for the trial and they will be followed up for 6 months after the interventions.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sirolimus Coated Angioplasty Balloon in the Salvage of Thrombosed Arteriovenous Graft
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : September 2, 2019
Actual Study Completion Date : September 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: Thrombosed Arteriovenous Graft
Single arm pilot study to investigate effect of sirolimus coated balloon in thrombosed arteriovenous graft
Device: Sirolimus Coated Balloon

Sirolimus has been used in organ transplantation as well as coronary stent due to its antiproliferative properties. It has been proven to has better outcome in animal studies compared to paclitaxel, which is about 22% in the sirolimus group versus 75% re-stenosis rate in paclitaxel group.

Sirolimus is coated on the surface of the angioplasty balloon and is transferred to the vessel wall when balloon is inflated and in contact with the vessel wall.

The following table compare sirolimus to paclitaxel. In which sirolimus works by cytostatic mechanism with a ten thousand fold of safety margin. And sirolimus's anti-restenosis effect is optimal with the benefit of lower level of competition and lesser tissue absorption and elution.

Other Name: Drug eluting device




Primary Outcome Measures :
  1. The patency rate of AVG at 3 months post sirolimus balloon angioplasty by performing surveillance ultrasound of AVG, assessing the thrill of AVG and assessing any dysfunctional vascular assess- related hospital admission. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. The patency rate of AVG at 6 months post sirolimus balloon angioplasty by performing surveillance ultrasound of AVG, assessing the thrill of AVG and assessing any dysfunctional vascular assess- related hospital admission. [ Time Frame: 6 months ]
  2. The number of intervention(s) needed to maintain patency of AVG. [ Time Frame: 6 months ]
  3. The cost effective of using sirolimus coated balloon in the management of thrombosed AVG by reviewing hospital bills related to dysfunctional dialysis access. [ Time Frame: 6 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 21-85 years
  2. Thrombosed AVG in the arm
  3. Successful thrombolysis of the thrombosed AVG, defined as the re-established of flow on Digital Subtraction Angiography (DSA) and restoration of thrill in the AVG on clinical examination

Exclusion Criteria:

  1. Patient unable to provide informed consent
  2. Previous bare metal stent or stent-graft placement within the dialysis access
  3. Presence of central vein stenosis
  4. Sepsis or active infection
  5. Recent intracranial bleed or gastrointestinal bleed within the past 12 months
  6. Allergy to iodinated contrast media, anti-platelet drugs, heparin or paclitaxel
  7. Pregnancy
  8. Life expectancy < 12 months based on physician's estimate (active malignancy)

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): NCT03666208


Locations
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Singapore
Singapore General Hospital Renal Department
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Investigators
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Principal Investigator: Chieh Suai Tan, Doctor Singapore General Hospital
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03666208    
Other Study ID Numbers: SCB
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
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
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