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

N

NexStep Medical

Status

Not yet enrolling

Conditions

Vascular Diseases

Treatments

Device: All'InCath CBC 035M Balloon Dilatation Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT05497440
CSP-0003

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

All'InCath CBC 035M Balloon Dilatation Catheter
Experimental group
Description:
All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.
Treatment:
Device: All'InCath CBC 035M Balloon Dilatation Catheter

Trial contacts and locations

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Central trial contact

Diane Marceau; Philippe Urbain

Data sourced from clinicaltrials.gov

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