Clinical Investigation of the Safety & Effectiveness of the VaSecure 018 Drug Coated PTA Balloon Catheter in the Treatment of Patients With Chronic Limb Threatening Ischemia (CLTI) Involving Below-the-Knee (BTK) Arteries

Vascuros Medical Pte Ltd7 sites in 3 countries46 target enrollmentOctober 30, 2018

ConditionsPeripheral Artery Disease Peripheral Vascular Disease Peripheral Arterial Occlusive Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Vascuros Medical Pte Ltd
Enrollment: 46
Locations: 7
Primary Endpoint: Freedom from a composite endpoint of Major adverse limb event (MALE) and procedure-related mortality.
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)

Detailed Description

The VaSecure Drug Coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty (PTA), after predilatation, of de novo lesions in the peripheral vasculature of the lower limb with reference vessel diameters of 2-4 mm. The study will include patients with lesions located in the infrapopliteal arteries diagnosed with CLTI of Rutherford categories 3-5. A maximum number of 46 patients will be enrolled in this clinical investigation in 7 sites in Europe and 2 in Singapore.

Registry

clinicaltrials.gov

Start Date

October 30, 2018

End Date

June 30, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Vascuros Medical Pte Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able to provide written informed consent prior to participating in the clinical investigation, e.g. patients are mentally able to understand the aim of the clinical investigation.
•Has a documented diagnosis of CLTI of Rutherford category 3-
•The target lesion must be de novo.
•Life expectancy is \>1 year, in the investigator's opinion.
•For women: menopausal or under active birth control.
•Patient must agree not to participate in any other clinical trial during 12 month follow-up period.
•Visual angiographic inclusion criteria
•Reference vessel(s) diameter is between 2mm-4mm. Each lesion in one or maximum two of the infrapopliteal arteries NOT extending beyond the ankle joint. Target lesion(s) consisting of a single solitary or series of multiple adjacent lesions (all less than 30 mm apart) in a single tibial vessel with a diameter stenosis ≥70% and a cumulative length of ≥50 mm to ≤250 mm. If there are two target lesions they will be separated for ≥3 cm and will be named from proximal to distal. Target lesion must be a tibial vessel (excluding popliteal artery) branching from popliteal artery.

Exclusion Criteria

•Breastfeeding or pregnant woman.
•Severe concentric calcification, documented by angiography using the COMPLIANCE360-Score (This scoring system takes into account both the arc of calcium (\< or \> 180º) and percent of lesion length (\< or \> 50%) as judged by fluoroscopy.) that could not be fully expanded by predilatation balloon and documented by angiography. Valid record up to 30 days before screening.
•Patients with major amputations that have already been performed or are planned, either on the target leg or on the contralateral side. .
•History of stroke within 3 months.
•History of myocardial infarction, thrombolysis or angina within 30 days prior to index procedure.
•Renal failure or chronic kidney disease with estimated Glomerular Filtration Rate (eGFR) ≤30 mL/min per 1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days of index procedure or treated with dialysis).
•Diagnosed active untreated systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure.
•Co-morbid conditions limiting life expectancy to \<12 months.
•Hemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy.
•Known allergy to paclitaxel or paclitaxel-related compounds or contrast media that cannot be adequately managed with pre- and post-procedure medication.

Outcomes

Primary Outcomes

Freedom from a composite endpoint of Major adverse limb event (MALE) and procedure-related mortality.

Time Frame: 30 days

Major adverse limb event is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure.

Secondary Outcomes

Procedure success rate(Index procedure or 1 day post index procedure)
Freedom from clinically-driven target lesion revascularization (cd-TLR) and target vessel revascularization (TVR)(3, 6, 9 and 12 months)
Incidence of all Adverse Events (AEs)(30 days, and 3, 6, 9 and 12 months)
Freedom from major target limb amputation(3, 6, 9 and 12 months)
Late Lumen Loss (LLL) of the target lesion(6 months)
Haemodynamic microvascular performance(Baseline, 6 and 12 months)
Clinical Improvement (combined endpoint) in amputation free, cd-TLR free, surviving patients(3, 6, 9 and 12 months)
Limb salvage(6 and 12 months)
Amputation-free survival(6 and 12 months)
Angiographic Restenosis(6 months)
Angiographic Restenotic Burden(6 months)
Freedom from occlusion (FFO) without cd-TLR on Duplex ultrasound(3, 6 and 9 months)
Wound healing rate(30 days, 3, 6, 9 and 12 months.)
Rutherford status(3, 6, 9 and 12 months)