Coronary Artery DiseaseNCT05908422
The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.
An observational study of Coronary Artery Disease and Coronary Disease, run by Alvimedica at 1 site in Turkey (Türkiye).
Trial summary
The objective of this prospective observational study is to collect clinical data on the medical device Alvision™ Interventional Cardiology Diagnostic Catheter in an unselected population in the current clinical practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Vascular Diseases
- What is being tested?
- Alvision™ Interventional Cardiology Diagnostic Catheter
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 15 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will consist of all patients in which the Alvision™ Interventional Cardiology Diagnostic Catheter is used who meet the study inclusion/exclusion criteria.
Who may be able to join
- Turkish citizen,
- ≥18 years of age,
- Has indication for a diagnostic coronarography according to Alvision™ Instruction for use,
- Has signed and dated the informed consent.
Who cannot join
- Having a known allergic reaction to any of the composition of Alvision™ Interventional Cardiology Diagnostic Catheter.
- Has synthetic vascular grafts through which the Alvision™ Interventional Cardiology Diagnostic Catheter should pass
- Participating in another medical device or pharmaceutical clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alvision™ Interventional Cardiology Diagnostic Catheter Use for Routine Diagnostic Procedures in Angiographic Applications: Evaluation of Safety and Performance in Everyday Clinical Practice. The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.
The objective of this prospective observational study is to collect clinical data on the medical device Alvision™ Interventional Cardiology Diagnostic Catheter in an unselected population in the current clinical practice
Read the detailed description
Within the scope of this observational medical device trial, brand/model of the catheter that will be used during the PCI will be decided by the physician and decision of the physician won't be interfered. PCI will be performed according to the standard clinical procedures. Data of the patients to whom Alvision™ Interventional Cardiology Diagnostic Catheter is applied will be gathered for the purpose of this study.
- Conditions
- Coronary Artery Disease, Coronary Disease, Vascular Diseases
- Being tested
- Alvision™ Interventional Cardiology Diagnostic Catheter
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alvision™ Interventional Cardiology Diagnostic CatheterDevice
The Alvision™ Interventional Cardiology Diagnostic Catheter is a single use only, thin, flexible single lumen tube, with a proximal hub, sterilized with ethylene oxide (EO) gas, non-pyrogenic. The product is defined as a catheter to inject a contrast medium into selected blood vessels.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of the successful delivery of radio-opaque media to selected sites in the coronary vascular system.
Measured: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Major adverse cardiovascular events (MACEs) and stroke associated with the use of diagnostic catheters until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure, whichever happens first:
- Thrombus formation/emboli
- Arterial wall damage
- Myocardial infarction
- Plaque dislodgement
- Cardiac arrhythmia
- Death
- Stroke
Measured: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Secondary outcomes (5)
Ratio of the successfully insertion catheter
Measured: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Capacity of providing the doctor with a safe and effective tool to perform angiographies
- Ratio of damage on vessels (%)
- Ratio of cardiogenic shock (%)
- Ratio of the straight course of the catheter through the vessels (%)
Measured: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Duration of the various stages the procedure (before the procedure, during and after the procedure) and a qualitative and quantitative assessment of angiographic quality
- Trackability (%)
- Torquability (%) ,
- Slippage (%) ,
Measured: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Ratio of the total volume of radio-opaque media delivered to the planned amount of using volume
Measured: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Determination of the relation between catheter size, and patients' height.
catheter size (cm) patients' height (cm)
Measured: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jan 2023
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvimedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908422
- Sponsor's protocol ID
- C42102
- Status last verified
- May 2024
- First submitted
- 30 May 2023
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alvision™ Interventional Cardiology Diagnostic Catheter Use for Routine Diagnostic Procedures in Angiographic Applications: Evaluation of Safety and Performance in Everyday Clinical Practice. The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.
- ClinicalTrials.gov ID
- NCT05908422
- Acronym / sponsor ID
- C42102
- Conditions
- Coronary Artery Disease, Coronary Disease, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AlvimedicaIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective observational study is to collect clinical data on the medical device Alvision™ Interventional Cardiology Diagnostic Catheter in an unselected population in the current clinical practice
Detailed description
Within the scope of this observational medical device trial, brand/model of the catheter that will be used during the PCI will be decided by the physician and decision of the physician won't be interfered. PCI will be performed according to the standard clinical procedures. Data of the patients to whom Alvision™ Interventional Cardiology Diagnostic Catheter is applied will be gathered for the purpose of this study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will consist of all patients in which the Alvision™ Interventional Cardiology Diagnostic Catheter is used who meet the study inclusion/exclusion criteria.
Key inclusion criteria (4 listed)
- Turkish citizen,
- ≥18 years of age,
- Has indication for a diagnostic coronarography according to Alvision™ Instruction for use,
- Has signed and dated the informed consent.
Key exclusion criteria (3 listed)
- Having a known allergic reaction to any of the composition of Alvision™ Interventional Cardiology Diagnostic Catheter.
- Has synthetic vascular grafts through which the Alvision™ Interventional Cardiology Diagnostic Catheter should pass
- Participating in another medical device or pharmaceutical clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alvision™ Interventional Cardiology Diagnostic CatheterThe Alvision™ Interventional Cardiology Diagnostic Catheter is a single use only, thin, flexible single lumen tube, with a proximal hub, sterilized with ethylene oxide (EO) gas, non-pyrogenic. The product is defined as a catheter to inject a contrast medium into selected blood vessels. | Device | – |
Primary outcome
Ratio of the successful delivery of radio-opaque media to selected sites in the coronary vascular system.
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Major adverse cardiovascular events (MACEs) and stroke associated with the use of diagnostic catheters until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure, whichever happens first:
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
* Thrombus formation/emboli * Arterial wall damage * Myocardial infarction * Plaque dislodgement * Cardiac arrhythmia * Death * Stroke
5 secondary outcomes
Ratio of the successfully insertion catheter
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Capacity of providing the doctor with a safe and effective tool to perform angiographies
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Duration of the various stages the procedure (before the procedure, during and after the procedure) and a qualitative and quantitative assessment of angiographic quality
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Ratio of the total volume of radio-opaque media delivered to the planned amount of using volume
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Determination of the relation between catheter size, and patients' height.
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Disease, run by Alvimedica at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of the successful delivery of radio-opaque media to selected sites in the coronary vascular system. (time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.