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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 (MERLION)

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ClinicalTrials.gov Identifier: NCT04073121
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Device: Luminor DCB and Angiolite DES Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Arm Intervention/treatment
Experimental: Luminor DCB and Angiolite DES
Study Devices
Device: Luminor DCB and Angiolite DES
Patient to undergo angioplasty with Luminor DCB and Angiolite DES




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Primary patency rate [ Time Frame: 6 and 12 months post operation ]
    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

  2. Technical success [ Time Frame: immediately post-operation ]
    Ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%

  3. Freedom from clinically-driven TLR [ Time Frame: 6 month follow-up ]
    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

  4. Clinical success at follow-up [ Time Frame: 1, 6 and 12 months post-operation ]
    Improvement of Rutherford Classification



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

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): NCT04073121


Contacts
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Contact: Charyl Yap 65767986 charyl.yap.j.q@sgh.com.sg

Locations
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Singapore
Singapore General Hospital Active, not recruiting
Singapore, Singapore, 169608
Khoo Teck Puat Hospital Recruiting
Singapore, Singapore, 768828
Principal Investigator: Chuo Ren Leong         
Sponsors and Collaborators
Singapore General Hospital
Investigators
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Principal Investigator: Tjun Yip Tang Singapore General Hospital
Publications:

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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT04073121    
Other Study ID Numbers: 2018/2800
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
Angioplasty
Drug Coated Balloon
Drug Coated Stents
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes