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

Clinical Evaluation of the All'InCath Contrast Balloon Catheter 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.

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.

Study Overview

• Status: Withdrawn
• Conditions: Vascular Diseases
• Intervention / Treatment: Device: All'InCath CBC 035M Balloon Dilatation Catheter

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All'InCath CBC 035M Balloon Dilatation Catheter; All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.	Device: All'InCath CBC 035M Balloon Dilatation Catheter; All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periprocedural Serious adverse events	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).	During procedure
Vascular patency	Vascular patency immediately post-procedure with adequate capability to ensure injection medium contrast into the vessel with a good visualization of the targeted area.	immediately post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the intervention (PTA)	Performance of the All'InCath Contrast Balloon Catheter 035M	Time of the procedure
Level of radiation exposure during PTA (mGy).	Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M	During procedure
Dose of contrast agent injected at the targeted location (mL).	Safety and performance of the All'InCath Contrast Balloon Catheter 035M	During procedure
Investigator's feedback	Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M	During procedure
Major adverse events during hospitalization until discharge	Safety of the All'InCath Contrast Balloon Catheter 035M	before hospital discharge or 24hours after the index-procedure which ever occurs first

Collaborators and Investigators

• Sponsor: NexStep Medical
• Investigators: Principal Investigator: Rabih Chaer, UPMC 200 Lothrop Street Pittsburgh, PA 15213

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): October 7, 2022

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: CSP-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Information about subjects will be considered confidential. Subject's identification must be anonymized at the site by the Investigator or designee, when completing the case report form (CRF), study-related worksheets, preparation of clinical reports or the preparation of subject medical records. Only authorized personnel might have access to these confidential files. Every reasonable effort will be made to protect the confidentiality of the subjects throughout the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes