Vascular Diseases
Conditions
Brief summary
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.
Detailed 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.
Interventions
All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.
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
* A participant will be eligible to participate in the study if all of the following apply: * 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periprocedural Serious adverse events | During procedure | Freedom from device related periprocedural adverse events and complications during PTA procedure (e.g., loss of guidewire, misdirection of catheter, vessel wall perforation or dissection requiring treatment). |
| Vascular patency | immediately post-procedure | Vascular patency immediately post-procedure with adequate capability to ensure injection medium contrast into the vessel with a good visualization of the targeted area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose of contrast agent injected at the targeted location (mL). | During procedure | Safety and performance of the All'InCath Contrast Balloon Catheter 035M |
| Duration of the intervention (PTA) | Time of the procedure | Performance of the All'InCath Contrast Balloon Catheter 035M |
| Major adverse events during hospitalization until discharge | before hospital discharge or 24hours after the index-procedure which ever occurs first | Safety of the All'InCath Contrast Balloon Catheter 035M |
| Investigator's feedback | During procedure | Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M |
| Level of radiation exposure during PTA (mGy). | During procedure | Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M |
Countries
United States
Outcome results
None listed