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The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
Full description
The All'InCath Contrast Balloon Catheter 035M Balloon Dilatation Catheter has received 510(k) clearance for Percutaneous Transluminal Angioplasty in the peripheral vasculature, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, and angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media (K191275).
The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter, including device-related perioperative adverse events, vascular patency, visualization of the target area, duration of intervention, level of radiation exposure, dose of contrast agent, post-procedural adverse events and physician's feedback, when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
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Inclusion and exclusion criteria
Inclusion Criteria:
A participant will be eligible to participate in the study if all of the following apply:
Ability to provide Informed Consent
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
The following subjects will be excluded from the study if any of the following criteria are met:
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:
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.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
Philippe Urbain; Diane Marceau
Data sourced from clinicaltrials.gov
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