Coronary Artery Disease ObliterativeNCT06030271
A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter
A study testing Microcatheter in people with Coronary Artery Disease Obliterative and Chronic Total Occlusion (CTO), run by Insight Lifetech Co., Ltd. at 7 sites in 3 countries.
Trial summary
The trial is a pivotal clinical investigation, which is a prospective, non-randomized pivotal clinical investigation to demonstrate the safety and performance of the TrueCross Single-use Microcatheter. Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- Coronary Artery Disease Obliterative, Chronic Total Occlusion (CTO)
- What is being tested?
- Microcatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 13 Oct 2022to 30 Mar 2023
- Phase
- Interventional
- 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 26 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are >25 years of age. ii. Subjects who are able/willing to provide a written informed consent prior to participating in the clinical investigation.
- The subject is male or, if female, is either not of childbearing potential or must use effective contraception during participation in this Clinical Investigation.
- Subject suffering from coronary artery disease requiring percutaneous coronary angiography and/or intervention.
- Lesions classified as CTOs, meaning, TIMI 0 flow within the occluded segment and angiographic or clinical evidence or high likelihood of an occlusion duration > 3 months vi. Reference vessel diameter ≥2 mm.
Who cannot join
- Coronary angiography and/or intervention contraindications. ii. Subjects with severe arrhythmia. iii. Subjects with severe systemic infection. iv. Subjects with severe coagulation disorder. v. Subjects with severe heart failure, unstable decompensated heart failure, congestive heart failure, or dyspnea who are unable to lie supine on the examination table for angiography.
- Subjects with prior coronary artery spams or prior heart valve replacement. vii. Currently participating in an investigational drug or another device clinical investigation that has not completed the primary endpoint or that clinically interferes with the current clinical investigation endpoints.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Georgia4 sites
Israeli-Georgian Medical Research Clinic Ltd - Healthycore Clinic
Tbilisi
Tbilisi Heart and Vascular Clinic
Tbilisi
Tbilisi Institute of Medicine
Tbilisi
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi
Greece2 sites
Onassis Heart Surgery Centre
Athens
Red Cross General Hospital
Athens
About this study
The trial is a pivotal clinical investigation, which is a prospective, non-randomized pivotal clinical investigation to demonstrate the safety and performance of the TrueCross Single-use Microcatheter.
Read the detailed description
The objective of this clinical investigation is to evaluate the performance and safety of the TrueCross Single-use Microcatheter in patients requiring a PCI procedure as well as the related clinical benefits.
The study will include 59 subjects suffering from coronary artery disease requiring a percutaneous coronary intervention. Enrollment duration will be 4 months or so without follow-up. It is a single-arm trial.In the uneventual case of a potential dropout (serious protocol deviation or procedure interruption unrelated to the catheter), subjects will be replaced to reach 59 evaluable subjects for the Per Protocol population.
- Being tested
- Microcatheter
- Keywords
- microcatheter, CTO, coronary artery disease, PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrocatheterDevice
Also called TrueCross
Support and facilitate the placement of the guidewire in the coronary artery with a CTO.
| Study group | Role | What they receive |
|---|---|---|
| TrueCross microcatheter | Experimental | The TrueCross Single-use Microcatheter will be used in percutaneous coronary intervention(PCI) of the enrolled subjects. Receives: Device: Microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance-technical success
Angiographic confirmation of the TrueCross Single-use Microcatheter's ability to support the guidewire in crossing the CTO in the target vessel true lumen.
Measured: during the procedure
Secondary outcomes (2)
Safety-observation of AE
Occurrence of any device related adverse event during use of the microcatheter throughout the procedure.
Occurrence of any non-device/procedure related events from screening start to the end of the procedure. This will include any events related or cause by other devices used independently from the TrueCross Single-use Microcatheter during the same PCI procedure.
Measured: ADE: during the procedure; non-device/procedure related AE: from screening start to the end of the procedure
Clinical Performance/Effectiveness
- Angiographic confirmation of successful placement and successful injection of contrast medium into the vessel lumen,
- Ability of exchange of the guidewire,
- Safe withdrawal of the TrueCross Single-use Microcatheter.
- Procedural efficiency measures (procedure time and injected contrast volume).
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start13 Oct 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease ObliterativeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insight Lifetech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030271
- Sponsor's protocol ID
- CIP-003C
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 8 Sep 2023
- 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter
- ClinicalTrials.gov ID
- NCT06030271
- Acronym / sponsor ID
- CIP-003C
- Keywords
- microcatheter, CTO, coronary artery disease, PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Insight Lifetech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 8 Sep 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 trial is a pivotal clinical investigation, which is a prospective, non-randomized pivotal clinical investigation to demonstrate the safety and performance of the TrueCross Single-use Microcatheter.
Detailed description
The objective of this clinical investigation is to evaluate the performance and safety of the TrueCross Single-use Microcatheter in patients requiring a PCI procedure as well as the related clinical benefits.
The study will include 59 subjects suffering from coronary artery disease requiring a percutaneous coronary intervention. Enrollment duration will be 4 months or so without follow-up. It is a single-arm trial.In the uneventual case of a potential dropout (serious protocol deviation or procedure interruption unrelated to the catheter), subjects will be replaced to reach 59 evaluable subjects for the Per Protocol population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TrueCross microcatheter | Experimental | Device: MicrocatheterThe TrueCross Single-use Microcatheter will be used in percutaneous coronary intervention(PCI) of the enrolled subjects. |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who are >25 years of age. ii. Subjects who are able/willing to provide a written informed consent prior to participating in the clinical investigation.
- The subject is male or, if female, is either not of childbearing potential or must use effective contraception during participation in this Clinical Investigation.
- Subject suffering from coronary artery disease requiring percutaneous coronary angiography and/or intervention.
- Lesions classified as CTOs, meaning, TIMI 0 flow within the occluded segment and angiographic or clinical evidence or high likelihood of an occlusion duration > 3 months vi. Reference vessel diameter ≥2 mm.
Key exclusion criteria (2 listed)
- Coronary angiography and/or intervention contraindications. ii. Subjects with severe arrhythmia. iii. Subjects with severe systemic infection. iv. Subjects with severe coagulation disorder. v. Subjects with severe heart failure, unstable decompensated heart failure, congestive heart failure, or dyspnea who are unable to lie supine on the examination table for angiography.
- Subjects with prior coronary artery spams or prior heart valve replacement. vii. Currently participating in an investigational drug or another device clinical investigation that has not completed the primary endpoint or that clinically interferes with the current clinical investigation endpoints.
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 |
|---|---|---|
| MicrocatheterAlso: TrueCrossSupport and facilitate the placement of the guidewire in the coronary artery with a CTO. | Device | TrueCross microcatheter |
Primary outcome
Clinical Performance-technical success
Time frame: during the procedure
Angiographic confirmation of the TrueCross Single-use Microcatheter's ability to support the guidewire in crossing the CTO in the target vessel true lumen.
2 secondary outcomes
Safety-observation of AE
Time frame: ADE: during the procedure; non-device/procedure related AE: from screening start to the end of the procedure
Clinical Performance/Effectiveness
Time frame: during the 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 8 Sep 2023.
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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcatheter in people with Coronary Artery Disease Obliterative and Chronic Total Occlusion (CTO), run by Insight Lifetech Co., Ltd. at 7 sites in 3 countries.
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 2 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Georgia, Greece, Singapore. 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?
Clinical Performance-technical success (time frame: during the 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 8 Sep 2023.