The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study
NCT ID: NCT05904951
Last Updated: 2024-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2022-12-01
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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INVADER™ PTCA Balloon Dilatation Catheter
INVADER™ PTCA Balloon Dilatation Catheter is a single use, EO sterilized, monorail rapid exchange (RX) coronary angioplasty balloon dilatation catheter. The INVADER™ PTCA has been designed to dilate the stenotic atherosclerotic lesions in coronary arteries or bypass grafts. The INVADER™ PTCA is an interventional, non-surgical device, and considered minimally invasive.
Eligibility Criteria
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Inclusion Criteria
* 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
* Device use not consistent with Instructions for Use (IFU).
* Patients concurrently participating in another medical device or pharmaceutical clinical trial.
18 Years
ALL
No
Sponsors
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Alvimedica
INDUSTRY
Responsible Party
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Locations
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Alvimedica
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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C32104
Identifier Type: -
Identifier Source: org_study_id
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