Vascular Diseases
Conditions
Brief summary
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities.
Detailed description
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
Interventions
Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.
Sponsors
NexStep Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide Informed Consent * Can also be executed by the legal designated representative or the witness * As per the Principal Investigator's practices as per standard of care, the subject is indicated for PTA in the peripheral vasculature, including iliac, femoral, popliteal, and renal arteries, and any treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. * Male or female \>18 years old. * Life expectancy \>1 year
Exclusion criteria
* Unstable coronary artery disease or any other uncontrolled comorbidity. * Myocardial infarction or stroke within two (2) months before baseline evaluation. * Previous peripheral bypass or procedure that includes the target vessel. * Known, untreated allergy or other contraindications to contrast agents or medications used during or after PTA. * Non-correctable bleeding diathesis, platelet dysfunction, thrombocytopenia, or any other known coagulopathy. * The use of antiplatelet or anticoagulant therapy is contraindicated. * Any planned major surgical or interventional procedure within 30 days after the study procedure. * Females who are breast-feeding or child-bearing potential and not using a medically reliable method of contraception (as defined below) for the entire study duration: * medically reliable contraception defined as: oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or those not using another method deemed by the Investigator to be sufficiently reliable. * subjects who are surgically sterilized / hysterectomized or post-menopausal for longer than two (2) years are not considered childbearing potential. * Positive pregnancy test result in women of child bearing potential or is breast-feeding. * Incapacitated individuals and those with psychiatric disorders that could interfere with the provision of informed consent, completion of tests, therapy, follow-up or general study compliance. * Participation in another study with investigational drug or device within the 30 days preceding and during the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the All'InCath Contrast Balloon Catheter 035M | immediately post-procedure | Periprocedural Serious Adverse Events |
| Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M | immediately post-procedure | Vascular patency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M | During Procedure | Level of radiation exposure during the PTA (mGy). |
| Performance of the All'InCath Contrast Balloon Catheter 035M | Time of Procedure | Duration of the PTA procedure. |
| Safety of the All'InCath Contrast Balloon Catheter 035M | 3 days | Post procedural adverse events |
| Safety and performance of the All'InCath Contrast Balloon Catheter 035M | During Procedure | Dose of injected contrast medium at the targeted location (mL) |
| Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M | During Procedure | Investigator opinion |
Countries
France
Outcome results
None listed