Clinical trial NCT05153421: Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.
Official title: Clinical Evaluation of the All'InCath CBC 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Diseases
Lead sponsor: NexStep Medical
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of the All'InCath Contrast Balloon Catheter 035M
timeFrame: immediately post-procedure
measure: Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M
timeFrame: immediately post-procedure
Secondary outcomes:
measure: Performance of the All'InCath Contrast Balloon Catheter 035M
timeFrame: Time of Procedure
measure: Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M
timeFrame: During Procedure
measure: Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M
timeFrame: During Procedure
measure: Safety and performance of the All'InCath Contrast Balloon Catheter 035M
timeFrame: During Procedure
measure: Safety of the All'InCath Contrast Balloon Catheter 035M
timeFrame: 3 days
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Geprovas
name: Fabien Thaveau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: