Coronary Artery DiseaseNCT05904951
The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) 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 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. 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?
- INVADER™ PTCA Balloon Dilatation Catheter
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 30 Apr 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 study population consisted of all consecutive patients treated with the INVADER™ PTCA at the study sites: all patients who met the inclusion/exclusion criteria were enrolled
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Coronary Artery Disease, Coronary Disease, Vascular Diseases
- Being tested
- INVADER™ PTCA Balloon Dilatation 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.
INVADER™ PTCA Balloon Dilatation CatheterDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success
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)
Measured: 48 hours after index procedure
Secondary outcomes (3)
Rate of individual components of device success
Measured: 48 hours after index procedure
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]).
Measured: 48 hours after index procedure
Rate of Target Lesion Failure (TLF)
- Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.
Measured: 48 hours after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Dec 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 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
- NCT05904951
- Sponsor's protocol ID
- C32104
- 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
- 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
- ClinicalTrials.gov ID
- NCT05904951
- Acronym / sponsor ID
- C32104
- 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 Dec 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 15 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 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.
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 study population consisted of all consecutive patients treated with the INVADER™ PTCA at the study sites: all patients who met the inclusion/exclusion criteria were enrolled
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| INVADER™ PTCA Balloon Dilatation CatheterINVADER™ 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. | Device | – |
Primary outcome
Device success
Time frame: 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)
3 secondary outcomes
Rate of individual components of device success
Time frame: 48 hours after index procedure
Procedural success:
Time frame: 48 hours after index procedure
Rate of Target Lesion Failure (TLF)
Time frame: 48 hours after index 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 5 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?
Device success (time frame: 48 hours after index procedure). 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.