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

NCT ID: NCT05153421

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2024-12-06

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.

Conditions

Vascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All'InCath CBC 035M Balloon Dilatation Catheter

Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.

Group Type: EXPERIMENTAL

All'InCath CBC 035M Balloon Dilatation Catheter

Intervention Type: DEVICE

Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.

Interventions

All'InCath CBC 035M Balloon Dilatation Catheter

Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NexStep Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabien Thaveau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Geprovas

Locations

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

CSP-0001

Identifier Type: -

Identifier Source: org_study_id