The VaSecure BTK Study

NCT03638115 | Unknown DMC

• 1 other identifier: SEC-BTK-001
• Study Type: interventional
• Target: 46
• Locations: 3 countries
• Sites: 7

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)

Conditions

Peripheral Artery Disease; Peripheral Vascular Disease; Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

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

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

  30 days

Secondary Outcomes (15)

• Procedure success rate

  Index procedure or 1 day post index procedure

• 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

• Freedom from clinically-driven target lesion revascularization (cd-TLR) and target vessel revascularization (TVR)

  3, 6, 9 and 12 months

• Late Lumen Loss (LLL) of the target lesion

  6 months

Study Arms (1)

VaSecure™ Drug Coated PTA Balloon Catheter

EXPERIMENTAL

Device: VaSecure™

Interventions

VaSecure™ DEVICE

Drug Coated PTA Balloon Catheter

VaSecure™ Drug Coated PTA Balloon Catheter

Eligibility Criteria

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

You may qualify if:

• 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 3-5.
• 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.
• 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.

You may not qualify if:

• 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.
• Is currently participating in an investigational drug or other investigational device study or previously enrolled in this study.
• Is unlikely to comply with the follow up schedule.
• Has uncontrolled ulcer wound infection.
• Is unwilling to comply with a concurrent ulcer wound therapy.
• Has an allergy to acetylsalicylic acid, prasugrel, ticagrelol, and clopidogrel (Plavix®).

Sponsors & Collaborators

• Vascuros Medical Pte Ltd: lead
• Novella Clinical: collaborator

Study Sites (7)

Ziekenhuis Oost Limburg

Genk, Belgium

NOT YET RECRUITING

Regionaal Ziekenhuis Heilig Hart

Tienen, Belgium

NOT YET RECRUITING

Klinikum Hoschsauerland

Arnsberg, Germany

NOT YET RECRUITING

Universitaetsklinikum Muenster

Münster, Germany

NOT YET RECRUITING

Regiomed Kliniken Sonneberg

Sonneberg, Germany

NOT YET RECRUITING

Changi General Hospital

Singapore, Singapore

RECRUITING

National University Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Thomas Zeller, MD

  Universitaets-Herzzentrum Freiburg - Bad Krozingen GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Lie

CONTACT

+6569096493; a.lie@vascuros.com

Study Design

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

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 20, 2018
• Study Start: October 30, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 30, 2020
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

BE (2); SG (2); DE (3)