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

Not Applicable

Withdrawn

• Conditions: Vascular Diseases
• Interventions: Device: All'InCath CBC 035M Balloon Dilatation Catheter

• Registration Number: NCT05497440
• Lead Sponsor: NexStep Medical

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.

Study Timeline

• Study Start: 2022-07-07
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 30

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All'InCath CBC 035M Balloon Dilatation Catheter	All'InCath CBC 035M Balloon Dilatation Catheter	All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Duration of the intervention (PTA)	Time of the procedure	Performance 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
Dose of contrast agent injected at the targeted location (mL).	During procedure	Safety and performance 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
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

Trial Locations

Locations (1)

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States