The FLUYDO NC Post Market Clinical Follow-up Study

• Sponsor: Alvimedica (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05965037
• Collaborator: CID S.p.A. (Industry)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 7.4
• Patients Per Site Per Month: 13.5

Study Details

Study Description

Brief Summary

The aim of the present observational study is to collect clinical data on the medical device non-implantable medical device Fluydo NC: coronary angioplasty non-compliant balloon dilatation catheter in the daily use in a not selected population.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Disease; Vascular Diseases	Device: FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Multicenter Prospective Registry in Current Clinical Practice With the Non-compliant Coronary Angioplasty Balloon Catheter. The FLUYDO NC Post Market Clinical Follow-up Study
• Actual Study Start Date: Nov 1, 2022
• Actual Primary Completion Date: Jun 15, 2023
• Actual Study Completion Date: Jun 15, 2023

Outcome Measures

Primary Outcome Measures

1. Device success [immediately after interventional procedure]

2. Successful inflation, achievement of appropriate diameter, and deflation of the balloon [immediately after interventional procedure]

3. Decrease in the percent stenosis after balloon procedure [immediately after interventional procedure]

4. No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade [immediately after interventional procedure]

5. No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation) [immediately after interventional procedure]

Secondary Outcome Measures

1. Procedural success: Measurement: Percentage of device success without major adverse cardiovascular events (MACE) (composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR)) [Discharge or 48 hours after index procedure, whichever happens first]

2. Rate of Target Lesion Failure (TLF) Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR. [discharge or 48 hours after index procedure, whichever happens first]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Turkish citizen,

• ≥18 years of age,

• Has indication for percutaneous transluminal coronary angioplasty (PTCA),

• Has indication to treat obstructive lesions of a native coronary artery or aortocoronary bypass or needs post dilatation of coronary stent

• Fluydo NC using in the primary lesion treated during the procedure by the decision physician,

• Has signed and dated the informed consent.

Exclusion Criteria:

• Has a previous diagnosis of coronary artery spasm in the absence of a significant stenosis.

• Needs the device use in an unprotected left main coronary artery

• Device use has not consistent with Instructions for Use.

• Participating in another medical device or pharmaceutical clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alvimedica	Istanbul		Turkey

Sponsors and Collaborators

• Alvimedica
• CID S.p.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alvimedica
• ClinicalTrials.gov Identifier: NCT05965037
• Other Study ID Numbers: C32103
• First Posted: Jul 28, 2023
• Last Update Posted: Jul 28, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Coronary Disease; Vascular Diseases

Study Results

No Results Posted as of Jul 28, 2023