The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study

• Sponsor: Alvimedica (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05904951
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 4.9
• Patients Per Site Per Month: 20.3

Study Details

Study Description

Brief Summary

The aim of the present observational study is to collect clinical data on the non-implantable medical device INVADER™ PTCA in the daily use in an unselected population.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Disease; Vascular Diseases	Device: INVADER™ PTCA Balloon Dilatation Catheter

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Balloon Dilatation Catheter for the Dilation of Stenotic Atherosclerotic Lesions in Coronary Artery or Bypass Grafts: Evaluation of Safety and Performance in Everyday Clinical Practice. The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study
• Actual Study Start Date: Dec 1, 2022
• Actual Primary Completion Date: Apr 30, 2023
• Actual Study Completion Date: Apr 30, 2023

Outcome Measures

Primary Outcome Measures

1. Device success [48 hours after index procedure]

   Measurement: Percentage of lesions among all attempted lesions with: Successful device delivery, and Successful inflation, achievement of appropriate diameter, and deflation of the balloon, and Decrease in the percent stenosis after balloon procedure, and No perforation, flow-limiting dissection or reduction in TIMI flow grade, and No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)

Secondary Outcome Measures

1. Rate of individual components of device success [48 hours after index procedure]

2. Procedural success: [48 hours after index procedure]

   o 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]).

3. Rate of Target Lesion Failure (TLF) [48 hours after index procedure]

   o Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• To be a Turkish citizen,

• To be >18 years of age,

• Lesion must be successfully crossed with a guidewire without complication,

• INVADER™ PTCA is used in the primary lesion treated during the procedure,

• Patient has signed and dated the informed consent.

Exclusion Criteria:

• Patients who have a known allergic reaction to any of the composition of INVADER™ PTCA Balloon Dilatation Catheter.

• Device use not consistent with Instructions for Use (IFU).

• Patients concurrently 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alvimedica
• ClinicalTrials.gov Identifier: NCT05904951
• Other Study ID Numbers: C32104
• First Posted: Jun 15, 2023
• Last Update Posted: Jun 15, 2023
• Last Verified: Jun 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 Jun 15, 2023