Peripheral Artery DiseaseFUTURE-SFANCT04511234
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
A study testing MagicTouch PTA sirolimus drug coated balloon (DCB) and POBA standard balloon in people with Peripheral Artery Disease and Atherosclerosis, run by Concept Medical Inc. at 20 sites in 3 countries.
Trial 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 superficial and popliteal arterial disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Artery Disease, Atherosclerosis, Arterial Disease
- What is being tested?
- MagicTouch PTA sirolimus drug coated balloon (DCB) and POBA standard balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 8 Sep 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years or minimum age
- Rutherford class 3 to 6 in the target limb
- Intraoperative Inclusion Criteria
- Single or sequential de novo or re-stenotic lesions (stenosis of > 50% or occlusions) from 2 to 20cm in the femoropopliteal arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Femoropopliteal arteries are superficial femoral artery, popliteal artery P1 and P2
- 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.
- At least one non-occluded crural vessel (ie. without significant stenosis) with angiographically documented run off to the foot.
Who cannot join
- Comorbid conditions limiting life expectancy ≤ 1 year
- Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
- Subject is pregnant or planning to become pregnant during the course of the study
- Heel gangrene
- Prior bypass surgery of target vessel
- Planned amputation of the target limb
Show all 16Show fewer
- Previously implanted stent in the target lesion
- Vulnerable or protected adults
- Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin
- Known allergy to sirolimus
- Intraoperative Exclusion Criteria
- 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)
- Failure to obtain <30% residual stenosis in a pre-existing lesion
- Highly calcific lesions
- Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)
- Lesions requiring retrograde access (SAFARI)
Trial locations and contacts
20 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 3 countries
Taiwan8 sites, 8 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Po-Chao Hsu, Dr.
- Recruiting
Kaoshiung Chang Gung Memorial Hospital
Kaohsiung City
Hsu Ting Yen, Dr.
- Recruiting
Far Eastern Memorial Hospital
New Taipei City
Chen Jer-Shen, Dr.
- Recruiting
Taipei Tzuchi Hospital
New Taipei City
Huang Hsuan-Li, Dr.
- Not yet recruiting
China Medical University Hospital
Taichung
Chung-Ho Hsu, Dr.
- Recruiting
National Taiwan University Hospital
Taipei
Lee Jen-Kuang, Dr.
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Lin Chia-Hsun, Dr.
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan City
Chen Chun-Chi, Dr.
Singapore6 sites, 6 recruiting
- Recruiting
Khoo Teck Puat Hospital
Singapore
Leong Chuo Ren
- Recruiting
National University Hospital
Singapore
Jackie Ho
- Not yet recruiting
Ng Teng Fong General Hospital
Singapore
Vikram Vijayan
- Recruiting
Sengkang General Hospital
Singapore
Kalpana Vijaykumar, Dr.
- Recruiting
Singapore General Hospital
Singapore
Chong Tze Tec, A/Prof
- Recruiting
Tan Tock Seng Hospital
Singapore
Pua Uei, Dr.
Thailand6 sites, 6 recruiting
- Recruiting
Phramongkutklao Hospital
Bangkok
Thatchawit Urasuk
- Recruiting
Rajavithi Hospital
Bangkok
Supachai Chanvitan, Dr.
- Not yet recruiting
Ramathibodi Hospital
Bangkok
Suthas Horsirimanont, Dr.
- Recruiting
Siriraj Hospital
Bangkok
Tossapol Prapassaro
- Recruiting
Vajira Hospital
Bangkok
Wuttichai Saengprakai, Dr.
- Recruiting
Thammasat University Hospital
Pathum Thani
Boonying Siribumrungwong
About this study
Official title: Randomized Controlled Trial of First Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Superficial Femoral Artery and Popliteal Artery Disease
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 superficial and popliteal arterial disease.
Read the 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.
- Conditions
- Peripheral Artery Disease, Atherosclerosis, Arterial Disease
- Being tested
- MagicTouch PTA sirolimus drug coated balloon (DCB), POBA standard balloon
- Keywords
- PAD, DCB, PTA, Sirolimus
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagicTouch PTA sirolimus drug coated balloon (DCB)Device
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 PTA sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
POBA standard balloonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MagicTouch PTA sirolimus drug coated balloon (DCB) | Experimental | MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty Receives: Device: MagicTouch PTA sirolimus drug coated balloon (DCB) |
| Placebo balloon angioplasty | Active comparator | Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA) Receives: Device: POBA standard balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency at 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)
Measured: 6 Months
Secondary outcomes (18)
Device and procedure related death
Proportion of device and procedure related death
Measured: 1, 6, 12 and 24 Months
All-cause death
Proportion of subjects died by any cause
Measured: 1, 6, 12 and 24 Months
Major target limb amputation
Proportion of major target limb amputation
Measured: 1, 6, 12 and 24 Months
Target vessel thrombosis
Proportion of subjects with target vessel thrombosis
Measured: From day 0 to day 14
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
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
Measured: Day 0 to day 14, 6 Months
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
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
Measured: From Day 0 to 24 Months Follow-up
Procedural Success
Proportion of subjects with procedural success during hospital stay
Measured: From Day 1 to discharge up to maximum of 30 days
Proportion of subjects who are free from clinically-driven Target Lesion Revascularization (TLR)
Proportion of subjects who are free from clinically-driven TLR
Measured: 6,12 and 24 Months
Proportion of subjects who are free from clinically-driven Target Vessel Revascularization (TVR)
Proportion of subjects who are free from clinically-driven Target Vessel Revascularization (TVR)
Measured: 6,12 and 24 Months
Primary patency
Primary patency rate at 12 and 24 months
Measured: 12 and 24 Months
Restenosis
Proportion of subjects with restenosis
Measured: 6, 12 and 24 Months
Subjects who are free from MAE
Proportion of subjects who are free from MAE
Measured: 6 Months
Amputation-free survival
Amputation-free survival
Measured: 6, 12 and 24 Months
Clinical Success
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
Measured: 6, 12 and 24 Months
Device success
Proportion of subjects with device success at day 1
Measured: Day 1
Technical success
Proportion of subjects with technical success at day 1
Measured: Day 1
Wound assessment (if any)
Wound assessment (if any)
Measured: 1, 6, 12, 24 Months
Toe Pressure or ABPI assessment
Toe Pressure or ABPI assessment
Measured: 6, 12, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start8 Sep 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concept Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Choke, Principal investigator, Sengkang General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511234
- Sponsor's protocol ID
- FUTURE SFA
- Acronym
- FUTURE-SFA
- Status last verified
- Jun 2025
- First submitted
- 5 Aug 2020
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giacoppo D, Cassese S, Harada Y, Colleran R, Michel J, Fusaro M, Kastrati A, Byrne RA. Drug-Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials. JACC Cardiovasc Interv. 2016 Aug 22;9(16):1731-42. doi: 10.1016/j.jcin.2016.06.008.
PubMed 27539695Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Bohm M, Speck U, Scheller B. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543. doi: 10.1161/CIRCINTERVENTIONS.115.003543.
PubMed 27069105Verheye S, Vrolix M, Kumsars I, Erglis A, Sondore D, Agostoni P, Cornelis K, Janssens L, Maeng M, Slagboom T, Amoroso G, Jensen LO, Granada JF, Stella P. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2029-2037. doi: 10.1016/j.jcin.2017.06.021. Epub 2017 Sep 27.
PubMed 28964764
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of First Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Superficial Femoral Artery and Popliteal Artery Disease
- ClinicalTrials.gov ID
- NCT04511234
- Acronym / sponsor ID
- FUTURE-SFA / FUTURE SFA
- Conditions
- Peripheral Artery Disease, Atherosclerosis, Arterial Disease
- Keywords
- PAD, DCB, PTA, Sirolimus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 279 participants (estimated)
- Lead sponsor
- Concept Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 superficial and popliteal arterial disease.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MagicTouch PTA sirolimus drug coated balloon (DCB) | Experimental | Device: MagicTouch PTA sirolimus drug coated balloon (DCB)MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty |
| Placebo balloon angioplasty | Active comparator | Device: POBA standard balloonPlacebo balloon angioplasty in addition to standard balloon angioplasty (PTA) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 21 years or minimum age
- Rutherford class 3 to 6 in the target limb
- Intraoperative Inclusion Criteria
- Single or sequential de novo or re-stenotic lesions (stenosis of > 50% or occlusions) from 2 to 20cm in the femoropopliteal arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Femoropopliteal arteries are superficial femoral artery, popliteal artery P1 and P2
- 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.
Key exclusion criteria (16 listed)
- Comorbid conditions limiting life expectancy ≤ 1 year
- Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
- Subject is pregnant or planning to become pregnant during the course of the study
- Heel gangrene
- Prior bypass surgery of target vessel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagicTouch PTA sirolimus drug coated balloon (DCB)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 PTA sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty. | Device | MagicTouch PTA sirolimus drug coated balloon (DCB) |
| POBA standard balloonFor 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. | Device | Placebo balloon angioplasty |
Primary outcome
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)
18 secondary outcomes
Device and procedure related death
Time frame: 1, 6, 12 and 24 Months
All-cause death
Time frame: 1, 6, 12 and 24 Months
Major target limb amputation
Time frame: 1, 6, 12 and 24 Months
Target vessel thrombosis
Time frame: From day 0 to day 14
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
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
Time frame: From Day 0 to 24 Months Follow-up
Procedural Success
Time frame: From Day 1 to discharge up to maximum of 30 days
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 Target Vessel Revascularization (TVR)
Time frame: 6,12 and 24 Months
Primary patency
Time frame: 12 and 24 Months
Restenosis
Time frame: 6, 12 and 24 Months
Subjects who are free from MAE
Time frame: 6 Months
Amputation-free survival
Time frame: 6, 12 and 24 Months
Clinical Success
Time frame: 6, 12 and 24 Months
Device success
Time frame: Day 1
Technical success
Time frame: Day 1
Wound assessment (if any)
Time frame: 1, 6, 12, 24 Months
Toe Pressure or ABPI assessment
Time frame: 6, 12, 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 27539695Giacoppo D, Cassese S, Harada Y, Colleran R, Michel J, Fusaro M, Kastrati A, Byrne RA. Drug-Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials. JACC Cardiovasc Interv. 2016 Aug 22;9(16):1731-42. doi: 10.1016/j.jcin.2016.06.008.
- Background: PubMed 27069105Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Bohm M, Speck U, Scheller B. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543. doi: 10.1161/CIRCINTERVENTIONS.115.003543.
- Background: PubMed 28964764Verheye S, Vrolix M, Kumsars I, Erglis A, Sondore D, Agostoni P, Cornelis K, Janssens L, Maeng M, Slagboom T, Amoroso G, Jensen LO, Granada JF, Stella P. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2029-2037. doi: 10.1016/j.jcin.2017.06.021. Epub 2017 Sep 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward Choke principal investigator
Sengkang General Hospital
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagicTouch PTA sirolimus drug coated balloon (DCB) and POBA standard balloon in people with Peripheral Artery Disease and Atherosclerosis, run by Concept Medical Inc. at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Taiwan, Singapore, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward Choke (+65 69302164, tcchoke@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency at 6 months (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511234, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.