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CompletedNCT04073121MERLIONUpdated Mar 17, 2021

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

An interventional study of Luminor DCB and Angiolite DES in Critical Limb Ischemia, sponsored by Singapore General Hospital. Completed at 2 sites in Singapore. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Singapore General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2018, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
21 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Critical Limb Ischemia

Keywords

  • Angioplasty
  • Drug Coated Balloon
  • Drug Coated Stents
03

In context

Chronic Limb-Threatening Ischemia

343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.

This study's enrollment of 50 is above the median of 45 across 233 interventional studies indexed under Chronic Limb-Threatening Ischemia.

Browse Chronic Limb-Threatening Ischemia studies →

Lead sponsor

Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Luminor DCB and Angiolite DES

    Study Devices

    Device: Luminor DCB and Angiolite DES

Interventions

  • DeviceLuminor DCB and Angiolite DES

    Patient to undergo angioplasty with Luminor DCB and Angiolite DES

06

What researchers measure

Primary outcomes

  1. Freedom from Major Adverse Events

    No device- and procedure-related mortality through 30 days, no major target limb amputation.

    Time frame: 30 days post-operation

  2. 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.

    Time frame: 12 months post-operation

Secondary outcomes

  1. 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

    Time frame: 6 and 12 months post operation

  2. Technical success

    Ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%

    Time frame: immediately post-operation

  3. 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

    Time frame: 6 month follow-up

  4. Clinical success at follow-up

    Improvement of Rutherford Classification

    Time frame: 1, 6 and 12 months post-operation

07

Study locations

2 sites
  • Singapore General Hospital
    Singapore, 169608, Singapore
  • Khoo Teck Puat Hospital
    Singapore, 768828, Singapore
08

References and documents

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 18727966 ↗
  • Christenson 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 25435663 ↗
  • Giles 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. Erratum In: J Vasc Surg. 2009 Nov;50(5):1249. Spence, T L [added]. PubMed 18502084 ↗
  • TASC 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 26268268 ↗
  • Soderstrom 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 21037432 ↗
  • Clark 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 11487672 ↗
  • Zeller 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04073121
Lead sponsor
Singapore General Hospital
Responsible party
Sponsor
First posted
Aug 29, 2019
Start date
Dec 27, 2018
Primary completion
Mar 10, 2020
Completion
Sep 30, 2020
Last update
Mar 17, 2021

Study contacts

Tjun Yip Tang
principal investigator · Singapore General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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