Critical Limb IschemiaMERLIONNCT04073121
Investigating the Safety and Efficacy of the Treatment With Luminor DCB and Angiolite DES of iVascular in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia
A study testing Luminor DCB and Angiolite DES in people with Critical Limb Ischemia, run by Singapore General Hospital at 2 sites in Singapore.
Trial summary
This study aims to evaluate the 12 month outcome of the mono- or combination therapy with iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial occlusive disease, presenting with critical limb ischemia. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Luminor DCB and Angiolite DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSingapore
- Study dates
- 27 Dec 2018to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 21 and above
- Patient has critical limb ischemia, presenting a score from 4 to 6 following Rutherford Classification
- Patient is willing to comply with the specified follow-up evaluations at specified time points
- Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a projected life expectancy of at least 12 months
- Prior to enrolment, the guidewire has crossed target lesion
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- Patient is eligible for treatment with Luminor Paclitaxel-Eluting Peripheral Balloon Dilation Catheter and Angiolite Drug Eluting Stent
- De novo and post-PTA restenotic lesions located in the tibial arteries suitable for endovascular surgery
- The target lesion is located within the native tibial artery
- The length of the target lesion is >100mm and considered as TASC C or D lesion according to TASC II Classification
- The target lesion has angiographic evidence of stenosis >50% or occlusion, which can be passed with standard guidewire manipulation
- Target vessel diameter visually estimated is >1.5mm and <4.5mm below the knee
- Either one or two different tibial arteries may be treated. Lesions in the treated segment may be continuous or may have gaps present between stenosis and occlusions.
- Any tibial vessel intervened on must have distal reconstitution above the ankle
- Inflow iliac, SFA and popliteal lesions can be treated during the same procedure using standard angioplasty and/or approved device. These inflow lesions must be treated first prior to consideration of the BTK lesion. The patient can be enrolled if the inflow lesions are treated with good angiographic results (must have <30% residual stenosis and no evidence of embolization).
- There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow-was established by means of previous endovascular intervention.
Who cannot join
- Patient refusing treatment
- Patient is permanently wheelchair-bound or bedridden
- Presence of a stent in the target lesions that was placed during a previous procedure
- Untreated flow-limiting inflow lesions
- Any previous surgery in the same limb
- Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
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- Previous bypass surgery in the same limb
- Patient for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated.
- Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
- Perforation at the angioplasty site evidenced by extravasation of contrast medium
- Patients with known hypersensitivity to heparin, including those patients who have a previous incidence of heparin-induced thrombocytopenia (HIT) type II
- Patients with uncorrected bleeding disorders
- Aneurysm located at the level of SFA/popliteal artery
- Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- Severe medical comorbidities (untreated CFA/CHF, severe COPD, metastatic malignancy, dementia, etc.) or other medical conditions that would preclude compliance with the study protocol or 1-year life expectancy
- Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
- Septicemia or bacteremia
- Patient has undrained pus or spreading wet gangrene in the foot that is not controlled at the time of revascularization procedure.
- Episode of acute limb ischemia within the previous 1 month
- Use of thrombectomy, atherectomy, or laser devices during procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure.
- Patient is participating in another research study of a device, medication, biologic or other agent within 30 days which could in the opinion of the investigator affect the results of this study.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital
Singapore, 169608
Khoo Teck Puat Hospital
Singapore, 768828
About this study
Official title: Physician Initiated, Prospective, Non-Randomized Multi-center Trial, Investigating the Safety and Efficacy of the Treatment With Luminor DCB and Angiolite DES of iVascular in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia
This study aims to evaluate the 12 month outcome of the mono- or combination therapy with iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial occlusive disease, presenting with critical limb ischemia.
Read the detailed description
Extensive arterial occlusions significantly reduces distal arterial perfusion, and may eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic pain, slow healing wounds at lower extremity and gangrene. It places patients with multi-segment occlusion at high risks of amputations and mortality.
The treatment methods for such long occlusive lesions are limited. Traditionally, the standard of care would be surgical revascularization. This is because lesion length have been identified in several studies as an independent risk factor for the development of restenosis after angioplasty and/or stenting. However, thanks to recent advances in endovascular techniques, such as the utilization of subintimal technique for crossing long segment occlusions, it is now possible to employ endovascular techniques for suitable patients.
The re-establishment of an in-line flow, even if only temporary, can allow tissue healing, which is vital in achieving limb salvage. In addition, the use of Drug Coated Balloons (DCB) and Drug Eluting Stents (DES) can potentially reduce restenosis rate.
To date, there are few studies that have evaluated the performance of DCB in lesions that are longer than 10cm. We hope to evaluate the performance of iVascular Luminor DCB and Angiolite DES when used in the treatment of such lesions.
- Conditions
- Critical Limb Ischemia
- Being tested
- Luminor DCB and Angiolite DES
- Keywords
- Angioplasty, Drug Coated Balloon, Drug Coated Stents
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminor DCB and Angiolite DESDevice
Patient to undergo angioplasty with Luminor DCB and Angiolite DES
| Study group | Role | What they receive |
|---|---|---|
| Luminor DCB and Angiolite DES | Experimental | Study Devices Receives: Device: Luminor DCB and Angiolite DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Major Adverse Events
No device- and procedure-related mortality through 30 days, no major target limb amputation.
Measured: 30 days post-operation
Freedom from Target Lesion Revascularization
No re-intervention performed for more than 50% diameter stenosis at the target lesion after documentation of recurrent clinical symptoms of patient.
Measured: 12 months post-operation
Secondary outcomes (4)
Primary patency rate
Absence of hemodynamically significant stenosis on duplex ultrasound (systolic velocity ration no greater than 2.5) at the target lesion and without TLR within the time of procedure and given follow-up
Measured: 6 and 12 months post operation
Technical success
Ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%
Measured: immediately post-operation
Freedom from clinically-driven TLR
Defined as absence of any repeat intervention to maintain and re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge
Measured: 6 month follow-up
Clinical success at follow-up
Improvement of Rutherford Classification
Measured: 1, 6 and 12 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start27 Dec 2018
- Primary completion10 Mar 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjun Yip Tang, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073121
- Sponsor's protocol ID
- 2018/2800
- Acronym
- MERLION
- Status last verified
- Mar 2021
- First submitted
- 26 Aug 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baril DT, Marone LK, Kim J, Go MR, Chaer RA, Rhee RY. Outcomes of endovascular interventions for TASC II B and C femoropopliteal lesions. J Vasc Surg. 2008 Sep;48(3):627-33. doi: 10.1016/j.jvs.2008.04.059.
PubMed 18727966Christenson BM, Rochon P, Gipson M, Gupta R, Smith MT. Treatment of infrapopliteal arterial occlusive disease in critical limb ischemia. Semin Intervent Radiol. 2014 Dec;31(4):370-4. doi: 10.1055/s-0034-1393974. No abstract available.
PubMed 25435663Giles KA, Pomposelli FB, Spence TL, Hamdan AD, Blattman SB, Panossian H, Schermerhorn ML. Infrapopliteal angioplasty for critical limb ischemia: relation of TransAtlantic InterSociety Consensus class to outcome in 176 limbs. J Vasc Surg. 2008 Jul;48(1):128-36. doi: 10.1016/j.jvs.2008.02.027. Epub 2008 May 23.
PubMed 18502084TASC Steering Committee; Jaff MR, White CJ, Hiatt WR, Fowkes GR, Dormandy J, Razavi M, Reekers J, Norgren L. An Update on Methods for Revascularization and Expansion of the TASC Lesion Classification to Include Below-the-Knee Arteries: A Supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Vasc Med. 2015 Oct;20(5):465-78. doi: 10.1177/1358863X15597877. Epub 2015 Aug 12.
PubMed 26268268Soderstrom MI, Arvela EM, Korhonen M, Halmesmaki KH, Alback AN, Biancari F, Lepantalo MJ, Venermo MA. Infrapopliteal percutaneous transluminal angioplasty versus bypass surgery as first-line strategies in critical leg ischemia: a propensity score analysis. Ann Surg. 2010 Nov;252(5):765-73. doi: 10.1097/SLA.0b013e3181fc3c73.
PubMed 21037432Clark TW, Groffsky JL, Soulen MC. Predictors of long-term patency after femoropopliteal angioplasty: results from the STAR registry. J Vasc Interv Radiol. 2001 Aug;12(8):923-33. doi: 10.1016/s1051-0443(07)61570-x.
PubMed 11487672Zeller T, Rastan A, Macharzina R, Tepe G, Kaspar M, Chavarria J, Beschorner U, Schwarzwalder U, Schwarz T, Noory E. Drug-coated balloons vs. drug-eluting stents for treatment of long femoropopliteal lesions. J Endovasc Ther. 2014 Jun;21(3):359-68. doi: 10.1583/13-4630MR.1.
PubMed 24915582
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Initiated, Prospective, Non-Randomized Multi-center Trial, Investigating the Safety and Efficacy of the Treatment With Luminor DCB and Angiolite DES of iVascular in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT04073121
- Acronym / sponsor ID
- MERLION / 2018/2800
- Conditions
- Critical Limb Ischemia
- Keywords
- Angioplasty, Drug Coated Balloon, Drug Coated Stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 29 Aug 2019 (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 evaluate the 12 month outcome of the mono- or combination therapy with iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial occlusive disease, presenting with critical limb ischemia.
Detailed description
Extensive arterial occlusions significantly reduces distal arterial perfusion, and may eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic pain, slow healing wounds at lower extremity and gangrene. It places patients with multi-segment occlusion at high risks of amputations and mortality.
The treatment methods for such long occlusive lesions are limited. Traditionally, the standard of care would be surgical revascularization. This is because lesion length have been identified in several studies as an independent risk factor for the development of restenosis after angioplasty and/or stenting. However, thanks to recent advances in endovascular techniques, such as the utilization of subintimal technique for crossing long segment occlusions, it is now possible to employ endovascular techniques for suitable patients.
The re-establishment of an in-line flow, even if only temporary, can allow tissue healing, which is vital in achieving limb salvage. In addition, the use of Drug Coated Balloons (DCB) and Drug Eluting Stents (DES) can potentially reduce restenosis rate.
To date, there are few studies that have evaluated the performance of DCB in lesions that are longer than 10cm. We hope to evaluate the performance of iVascular Luminor DCB and Angiolite DES when used in the treatment of such lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luminor DCB and Angiolite DES | Experimental | Device: Luminor DCB and Angiolite DESStudy Devices |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient 21 and above
- Patient has critical limb ischemia, presenting a score from 4 to 6 following Rutherford Classification
- Patient is willing to comply with the specified follow-up evaluations at specified time points
- Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a projected life expectancy of at least 12 months
Key exclusion criteria (23 listed)
- Patient refusing treatment
- Patient is permanently wheelchair-bound or bedridden
- Presence of a stent in the target lesions that was placed during a previous procedure
- Untreated flow-limiting inflow lesions
- Any previous surgery in the same limb
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 |
|---|---|---|
| Luminor DCB and Angiolite DESPatient to undergo angioplasty with Luminor DCB and Angiolite DES | Device | Luminor DCB and Angiolite DES |
Primary outcome
Freedom from Major Adverse Events
Time frame: 30 days post-operation
No device- and procedure-related mortality through 30 days, no major target limb amputation.
Freedom from Target Lesion Revascularization
Time frame: 12 months post-operation
No re-intervention performed for more than 50% diameter stenosis at the target lesion after documentation of recurrent clinical symptoms of patient.
4 secondary outcomes
Primary patency rate
Time frame: 6 and 12 months post operation
Technical success
Time frame: immediately post-operation
Freedom from clinically-driven TLR
Time frame: 6 month follow-up
Clinical success at follow-up
Time frame: 1, 6 and 12 months post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 18727966Baril DT, Marone LK, Kim J, Go MR, Chaer RA, Rhee RY. Outcomes of endovascular interventions for TASC II B and C femoropopliteal lesions. J Vasc Surg. 2008 Sep;48(3):627-33. doi: 10.1016/j.jvs.2008.04.059.
- Background: PubMed 25435663Christenson BM, Rochon P, Gipson M, Gupta R, Smith MT. Treatment of infrapopliteal arterial occlusive disease in critical limb ischemia. Semin Intervent Radiol. 2014 Dec;31(4):370-4. doi: 10.1055/s-0034-1393974. No abstract available.
- Background: PubMed 18502084Giles KA, Pomposelli FB, Spence TL, Hamdan AD, Blattman SB, Panossian H, Schermerhorn ML. Infrapopliteal angioplasty for critical limb ischemia: relation of TransAtlantic InterSociety Consensus class to outcome in 176 limbs. J Vasc Surg. 2008 Jul;48(1):128-36. doi: 10.1016/j.jvs.2008.02.027. Epub 2008 May 23.
- Background: PubMed 26268268TASC Steering Committee; Jaff MR, White CJ, Hiatt WR, Fowkes GR, Dormandy J, Razavi M, Reekers J, Norgren L. An Update on Methods for Revascularization and Expansion of the TASC Lesion Classification to Include Below-the-Knee Arteries: A Supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Vasc Med. 2015 Oct;20(5):465-78. doi: 10.1177/1358863X15597877. Epub 2015 Aug 12.
- Background: PubMed 21037432Soderstrom MI, Arvela EM, Korhonen M, Halmesmaki KH, Alback AN, Biancari F, Lepantalo MJ, Venermo MA. Infrapopliteal percutaneous transluminal angioplasty versus bypass surgery as first-line strategies in critical leg ischemia: a propensity score analysis. Ann Surg. 2010 Nov;252(5):765-73. doi: 10.1097/SLA.0b013e3181fc3c73.
- Background: PubMed 11487672Clark TW, Groffsky JL, Soulen MC. Predictors of long-term patency after femoropopliteal angioplasty: results from the STAR registry. J Vasc Interv Radiol. 2001 Aug;12(8):923-33. doi: 10.1016/s1051-0443(07)61570-x.
- Background: PubMed 24915582Zeller T, Rastan A, Macharzina R, Tepe G, Kaspar M, Chavarria J, Beschorner U, Schwarzwalder U, Schwarz T, Noory E. Drug-coated balloons vs. drug-eluting stents for treatment of long femoropopliteal lesions. J Endovasc Ther. 2014 Jun;21(3):359-68. doi: 10.1583/13-4630MR.1.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tjun Yip Tang principal investigator
Singapore General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luminor DCB and Angiolite DES in people with Critical Limb Ischemia, run by Singapore General Hospital at 2 sites in Singapore.
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 16 inclusion and 23 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: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Major Adverse Events (time frame: 30 days post-operation). The study lists 2 primary outcomes in all. 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 NCT04073121, which also lists 7 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 17 Mar 2021.