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
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia||Device: Luminor DCB and Angiolite DES||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Luminor DCB and Angiolite DES
Device: Luminor DCB and Angiolite DES
Patient to undergo angioplasty with Luminor DCB and Angiolite DES
- 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.
- 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
- Technical success [ Time Frame: immediately post-operation ]Ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%
- 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
- Clinical success at follow-up [ Time Frame: 1, 6 and 12 months post-operation ]Improvement of Rutherford Classification
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
|Contact: Charyl Yapemail@example.com|
|Singapore General Hospital||Active, not recruiting|
|Singapore, Singapore, 169608|
|Khoo Teck Puat Hospital||Recruiting|
|Singapore, Singapore, 768828|
|Principal Investigator: Chuo Ren Leong|
|Principal Investigator:||Tjun Yip Tang||Singapore General Hospital|