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

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:
• •* 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.