- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03638115
The VaSecure BTK Study
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anthony Lie
- Phone Number: +6569096493
- Email: a.lie@vascuros.com
Study Locations
-
-
-
Genk, Belgium
- Not yet recruiting
- Ziekenhuis Oost Limburg
-
Tienen, Belgium
- Not yet recruiting
- Regionaal Ziekenhuis Heilig Hart
-
-
-
-
-
Arnsberg, Germany
- Not yet recruiting
- Klinikum Hoschsauerland
-
Münster, Germany
- Not yet recruiting
- Universitaetsklinikum Muenster
-
Principal Investigator:
- Nasser Malyar, MD
-
Sonneberg, Germany
- Not yet recruiting
- Regiomed Kliniken Sonneberg
-
-
-
-
-
Singapore, Singapore
- Recruiting
- National University Hospital
-
Principal Investigator:
- Pei Ho, MD
-
Singapore, Singapore
- Recruiting
- Changi General Hospital
-
Principal Investigator:
- Yih Kai Tan, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 3-5.
- 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.
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.
- 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®).
Use of atherectomy in proximal vessels or TL. However, the use of scoring/cutting balloons in the TL is allowed.
Angiographic exclusion criteria
- Lesions that cannot be successfully predilated to achieve a residual stenosis of <50% by visual estimate.
- Severe dissection post dilatation resulting in a flow limiting lesion.
- Thrombus in the target vessel documented by angiography.
- Aneurysm in the target vessel(s).
- Treatment of the contralateral limb during the same index procedure or within 30 days post-index procedure in order to avoid confounding complications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: VaSecure™ Drug Coated PTA Balloon Catheter
|
Drug Coated PTA Balloon Catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedure success rate
Time Frame: Index procedure or 1 day post index procedure
|
Composite of technical success defined as successful vascular access and completion of the endovascular procedure as well as immediate morphological success with <30% residual reduction in diameter as assessed by QVA and Device success defined as exact deployment of the device according to the Instructions For Use (IFU) as documented by suitable imaging means
|
Index procedure or 1 day post index procedure
|
Incidence of all Adverse Events (AEs)
Time Frame: 30 days, and 3, 6, 9 and 12 months
|
All AEs will be characterized by severity, relatedness, outcome and treatment
|
30 days, and 3, 6, 9 and 12 months
|
Freedom from major target limb amputation
Time Frame: 3, 6, 9 and 12 months
|
Rates of amputation of the lower limb above 1 cm from the ankle mortice/joint upwards
|
3, 6, 9 and 12 months
|
Freedom from clinically-driven target lesion revascularization (cd-TLR) and target vessel revascularization (TVR)
Time Frame: 3, 6, 9 and 12 months
|
Clinically-driven TLR is defined by core lab confirmation of restenosis ≥70% in the target lesion with wound persistence, new wounds or re-occurence of ischemic rest pain
|
3, 6, 9 and 12 months
|
Late Lumen Loss (LLL) of the target lesion
Time Frame: 6 months
|
As measured by QVA
|
6 months
|
Angiographic Restenosis
Time Frame: 6 months
|
Defined as ≥70% diameter stenosis on 2-view angiography by visual estimate
|
6 months
|
Angiographic Restenotic Burden
Time Frame: 6 months
|
Defined as the percentage of length of stenosis/occlusion ≥70% on 2-view angiography by visual estimate in mm, divided by the total length of the lesion in mm
|
6 months
|
Freedom from occlusion (FFO) without cd-TLR on Duplex ultrasound
Time Frame: 3, 6 and 9 months
|
Defined as presence of flow on colour doppler of the target lesion
|
3, 6 and 9 months
|
Haemodynamic microvascular performance
Time Frame: Baseline, 3, 6 and 12 months
|
As measured by transcutaneous oxygen (TcpO2)
|
Baseline, 3, 6 and 12 months
|
Haemodynamic microvascular performance
Time Frame: Baseline, 6 and 12 months
|
As measured by Ankle-Brachial-Index (ABI).
|
Baseline, 6 and 12 months
|
Wound healing rate
Time Frame: 30 days, 3, 6, 9 and 12 months.
|
Defined as healed or not, if not, improving, stagnant or worsening
|
30 days, 3, 6, 9 and 12 months.
|
Rutherford status
Time Frame: 3, 6, 9 and 12 months
|
Change in Rutherford classification as assessed by the investigator
|
3, 6, 9 and 12 months
|
Clinical Improvement (combined endpoint) in amputation free, cd-TLR free, surviving patients
Time Frame: 3, 6, 9 and 12 months
|
Specified as an improvement shift in the Rutherford classification of one class.
|
3, 6, 9 and 12 months
|
Limb salvage
Time Frame: 6 and 12 months
|
Defined as preservation of a functional foot without the need for a leg prosthesis
|
6 and 12 months
|
Amputation-free survival
Time Frame: 6 and 12 months
|
Defined as composite endpoint of mortality and amputation
|
6 and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Zeller, MD, Universitaets-Herzzentrum Freiburg - Bad Krozingen GmbH
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEC-BTK-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Arterial Occlusive Disease
-
CID S.p.A.Meditrial Europe Ltd.Not yet recruitingPeripheral Arterial Occlusive Disease | Peripheral Artery DiseaseItaly
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Diseases | Peripheral Arterial Occlusive Disease | Peripheral Artery DiseaseUnited States
-
Western Vascular Institute, IrelandRecruitingPeripheral Arterial Occlusive DiseaseIreland
-
Jena University HospitalAngioDroid s.r.l., Bologna (Italy)CompletedPeripheral Arterial Occlusive DiseaseGermany
-
Seoul National University HospitalAstellas Pharma Korea, Inc.CompletedPeripheral Arterial Occlusive DiseaseKorea, Republic of
-
Heidelberg UniversityTerminatedPeripheral Arterial Occlusive DiseaseGermany
-
Johann Wolfgang Goethe University HospitalSuspendedPeripheral Arterial Occlusive DiseaseGermany
-
Baltimore VA Medical CenterCompletedPeripheral Arterial Occlusive DiseaseUnited States
-
University Heart Center Freiburg - Bad KrozingenJohann Wolfgang Goethe University HospitalCompletedPeripheral Arterial Occlusive DiseaseGermany
-
St. Antonius HospitalUMC Utrecht; Albert Schweitzer Hospital; Amphia HospitalUnknownAtherosclerosis | Peripheral Arterial Occlusive DiseaseNetherlands
Clinical Trials on VaSecure™
-
BaroNova, Inc.Completed
-
London Health Sciences CentreUniversity of Western Ontario, Canada; Synaptive MedicalUnknownBrain Damage, Chronic | Cerebellar Cognitive Affective Syndrome | Cerebellar Mutism
-
Asklepios Kliniken Hamburg GmbHUniversity of KielCompletedAirway Management | Laryngeal Mask Airway | Fibreoptic Intubation
-
CereVasc IncAlvaMed, Inc.; Simplified Clinical Data Systems, LLC; Bioscience Consulting,...RecruitingHydrocephalus | Hydrocephalus, CommunicatingArgentina
-
Medtronic CardiovascularActive, not recruitingAortic AneurysmGermany, New Zealand, United States, Netherlands, Switzerland, United Kingdom, Spain, Australia, Italy, Sweden, France, Austria, Slovakia
-
Gülçin Özalp GerçekerCompletedCatheter Complications | Catheter LeakageTurkey
-
Andrew ParrentUniversity of Western Ontario, Canada; Synaptive MedicalUnknownTemporal Lobe Epilepsy
-
Medtronic CardiovascularMedtronicCompletedAortic StenosisNew Zealand, United Kingdom, Australia
-
GlaxoSmithKlineCompletedTetanus | Diphtheria | Acellular Pertussis | Poliomyelitis | Haemophilus Influenzae Type bKorea, Republic of
-
GlaxoSmithKlineCompletedHepatitis B | Hepatitis AGermany, Belgium, Czechia