Clinical trial NCT03638115: The VaSecure BTK Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Peripheral Arterial Occlusive Disease
Lead sponsor: Vascuros Medical Pte Ltd
Sponsor class: INDUSTRY
Collaborators: name: Novella Clinical
First posted: 2018-08-20
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Has a documented diagnosis of CLTI of Rutherford category 3-5.
3. The target lesion must be de novo.
4. Life expectancy is \>1 year, in the investigator's opinion.
5. For women: menopausal or under active birth control.
6. Patient must agree not to participate in any other clinical trial during 12 month follow-up period.

   Visual angiographic inclusion criteria
7. 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:

1. Breastfeeding or pregnant woman.
2. 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.
3. Patients with major amputations that have already been performed or are planned, either on the target leg or on the contralateral side. .
4. History of stroke within 3 months.
5. History of myocardial infarction, thrombolysis or angina within 30 days prior to index procedure.
6. 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).
7. Diagnosed active untreated systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure.
8. Co-morbid conditions limiting life expectancy to \<12 months.
9. 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.
10. Known allergy to paclitaxel or paclitaxel-related compounds or contrast media that cannot be adequately managed with pre- and post-procedure medication.
11. Is currently participating in an investigational drug or other investigational device study or previously enrolled in this study.
12. Is unlikely to comply with the follow up schedule.
13. Has uncontrolled ulcer wound infection.
14. Is unwilling to comply with a concurrent ulcer wound therapy.
15. Has an allergy to acetylsalicylic acid, prasugrel, ticagrelol, and clopidogrel (Plavix®).
16. Use of atherectomy in proximal vessels or TL. However, the use of scoring/cutting balloons in the TL is allowed.

    Angiographic exclusion criteria
17. Lesions that cannot be successfully predilated to achieve a residual stenosis of \<50% by visual estimate.
18. Severe dissection post dilatation resulting in a flow limiting lesion.
19. Thrombus in the target vessel documented by angiography.
20. Aneurysm in the target vessel(s).
21. Treatment of the contralateral limb during the same index procedure or within 30 days post-index procedure in order to avoid confounding complications.

Primary outcomes:
measure: Freedom from a composite endpoint of Major adverse limb event (MALE) and procedure-related mortality.
timeFrame: 30 days
Secondary outcomes:
measure: Procedure success rate
timeFrame: Index procedure or 1 day post index procedure
measure: Incidence of all Adverse Events (AEs)
timeFrame: 30 days, and 3, 6, 9 and 12 months
measure: Freedom from major target limb amputation
timeFrame: 3, 6, 9 and 12 months
measure: Freedom from clinically-driven target lesion revascularization (cd-TLR) and target vessel revascularization (TVR)
timeFrame: 3, 6, 9 and 12 months
measure: Late Lumen Loss (LLL) of the target lesion
timeFrame: 6 months
measure: Angiographic Restenosis
timeFrame: 6 months
measure: Angiographic Restenotic Burden
timeFrame: 6 months
measure: Freedom from occlusion (FFO) without cd-TLR on Duplex ultrasound
timeFrame: 3, 6 and 9 months
measure: Haemodynamic microvascular performance
timeFrame: Baseline, 3, 6 and 12 months
measure: Haemodynamic microvascular performance
timeFrame: Baseline, 6 and 12 months
measure: Wound healing rate
timeFrame: 30 days, 3, 6, 9 and 12 months.
measure: Rutherford status
timeFrame: 3, 6, 9 and 12 months
measure: Clinical Improvement (combined endpoint) in amputation free, cd-TLR free, surviving patients
timeFrame: 3, 6, 9 and 12 months
measure: Limb salvage
timeFrame: 6 and 12 months
measure: Amputation-free survival
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Tienen
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart
city: Arnsberg
country: Germany
facility: Klinikum Hoschsauerland
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster
city: Sonneberg
country: Germany
facility: Regiomed Kliniken Sonneberg
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: Universitaets-Herzzentrum Freiburg - Bad Krozingen GmbH
name: Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
References: