Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of the All'InCath CBC 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.

Conditions
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Vascular Diseases

Intervention / Treatment
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* Device: All'InCath CBC 035M Balloon Dilatation Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All'InCath CBC 035M Balloon Dilatation Catheter<br>Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter. | Device: All'InCath CBC 035M Balloon Dilatation Catheter<br>* Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the All'InCath Contrast Balloon Catheter 035M | Periprocedural Serious Adverse Events | immediately post-procedure | 
| Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M | Vascular patency | immediately post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the All'InCath Contrast Balloon Catheter 035M | Duration of the PTA procedure. | Time of Procedure | 
| Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M | Investigator opinion | During Procedure | 
| Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M | Level of radiation exposure during the PTA (mGy). | During Procedure | 
| Safety and performance of the All'InCath Contrast Balloon Catheter 035M | Dose of injected contrast medium at the targeted location (mL) | During Procedure | 
| Safety of the All'InCath Contrast Balloon Catheter 035M | Post procedural adverse events | 3 days |