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

NCT04073121 | Completed

• 1 other identifier: 2018/2800
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Limb Ischemia

Keywords

Angioplasty; Drug Coated Balloon; Drug Coated Stents

Outcome Measures

Primary Outcomes (2)

• Freedom from Major Adverse Events

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

  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.

  12 months post-operation

Secondary Outcomes (4)

• Primary patency rate

  6 and 12 months post operation

• Technical success

  immediately post-operation

• Freedom from clinically-driven TLR

  6 month follow-up

• Clinical success at follow-up

  1, 6 and 12 months post-operation

Study Arms (1)

Luminor DCB and Angiolite DES

EXPERIMENTAL

Study Devices

Device: Luminor DCB and Angiolite DES

Interventions

Luminor DCB and Angiolite DES DEVICE

Patient to undergo angioplasty with Luminor DCB and Angiolite DES

Luminor DCB and Angiolite DES

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

Related Publications (7)

• 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.

  PMID: 18727966 BACKGROUND

• 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.

  PMID: 25435663 BACKGROUND

• 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.

  PMID: 18502084 BACKGROUND

• 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.

  PMID: 26268268 BACKGROUND

• 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.

  PMID: 21037432 BACKGROUND

• 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.

  PMID: 11487672 BACKGROUND

• 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.

  PMID: 24915582 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Tjun Yip Tang

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 29, 2019
• Study Start: December 27, 2018
• Primary Completion: March 10, 2020
• Study Completion: September 30, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)