Angina PectorisCTO_BVSNCT06164977
Chronic Total Coronary Occlusion Treatment Results 6 Years After Bioresorbable Scaffold Implantation
A study testing Percutaneous coronary intervention. in people with Angina Pectoris and Coronary Artery Disease, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
Trial summary
Aim of the study is to evaluate chronic total coronary occlusion treatment results 6 years after bioresorbable scaffold implantation by quantitative coronary analysis, intravascular ultrasound and optical coherence tomography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina Pectoris, Coronary Artery Disease, Occlusion, Coronary
- What is being tested?
- Percutaneous coronary intervention.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteLatvia
- Study dates
- 1 Feb 2017to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 100% occlusion of a coronary artery for a duration of greater than or equal to 3 months based on angiographic evidence.
Who cannot join
- Participant withdrawal from study.
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study is to evaluate chronic total coronary occlusion treatment results 6 years after bioresorbable scaffold implantation by quantitative coronary analysis, intravascular ultrasound and optical coherence tomography.
Read the detailed description
The study aims to assess the outcomes of treating chronic total coronary occlusion (CTO) using bioresorbable scaffolds six years after implantation. The evaluation employs quantitative coronary analysis (QCA), intravascular ultrasound (IVUS), and optical coherence tomography (OCT) as invasive imaging tools. Clinical follow-ups were conducted at one and six years post-implantation to ensure a comprehensive understanding of the long-term safety and feasibility of bioresorbable scaffold implantation for CTO.
The primary outcome measure is defined as the target lesion failure of the treated chronic total coronary occlusion segment. Target lesion failure typically encompasses a composite endpoint that includes clinical events such as cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization.
The use of QCA allows for the quantitative assessment of the coronary arteries, providing measurements of vessel diameter and lesion length. IVUS is employed to obtain detailed images of the vessel wall, helping to visualize the morphology of the treated segment and assess the presence of any complications such as stent malapposition or edge dissections. OCT, with its high resolution, allows for detailed imaging of the coronary artery, providing information on plaque composition and stent apposition.
By combining these invasive imaging tools with clinical follow-ups at specified intervals, the study aims to provide a comprehensive evaluation of the long-term efficacy and safety of bioresorbable scaffold implantation in the treatment of chronic total coronary occlusion. The focus on target lesion failure as the primary outcome measure ensures a clinically relevant assessment of the success of the intervention.
- Being tested
- Percutaneous coronary intervention.
- Keywords
- Atherosclerosis, Chronic total coronary occlusion, Intravascular ultrasound, Optic coherence tomography
- Medical subject headings
- Angina Pectoris, Coronary Artery Disease, Coronary Occlusion, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention.Procedure or surgery
Revascularization of chronic total coronary occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Chronic total coronary occlusion | Other | Participants who underwent percutaneous coronary intervention for chronic total coronary occlusion revascularization with bioresorbable scaffold. Receives: Procedure: Percutaneous coronary intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure
Target Lesion Failure (TLF) will be assessed as the number of participants experiencing at least one of the following events during the follow-up period: cardiovascular death, clinically driven target lesion revascularization, target vessel myocardial infarction and stent thrombosis according to the Academic Research Consortium.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Feb 2017
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies 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
- Model description
- Single group consists of study participants who where treated for chronic total coronary occlusion with bioresorbable scaffolds
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pauls Stradins Clinical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164977
- Sponsor's protocol ID
- CTO_BVS
- Acronym
- CTO_BVS
- Status last verified
- Jun 2025
- First submitted
- 22 Nov 2023
- Last updated
- 11 Jun 2025
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Total Coronary Occlusion Treatment Results 6 Years After Bioresorbable Scaffold Implantation
- ClinicalTrials.gov ID
- NCT06164977
- Acronym / sponsor ID
- CTO_BVS / CTO_BVS
- Keywords
- Atherosclerosis, Chronic total coronary occlusion, Intravascular ultrasound, Optic coherence tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pauls Stradins Clinical University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 11 Dec 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.
Aim of the study is to evaluate chronic total coronary occlusion treatment results 6 years after bioresorbable scaffold implantation by quantitative coronary analysis, intravascular ultrasound and optical coherence tomography.
Detailed description
The study aims to assess the outcomes of treating chronic total coronary occlusion (CTO) using bioresorbable scaffolds six years after implantation. The evaluation employs quantitative coronary analysis (QCA), intravascular ultrasound (IVUS), and optical coherence tomography (OCT) as invasive imaging tools. Clinical follow-ups were conducted at one and six years post-implantation to ensure a comprehensive understanding of the long-term safety and feasibility of bioresorbable scaffold implantation for CTO.
The primary outcome measure is defined as the target lesion failure of the treated chronic total coronary occlusion segment. Target lesion failure typically encompasses a composite endpoint that includes clinical events such as cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization.
The use of QCA allows for the quantitative assessment of the coronary arteries, providing measurements of vessel diameter and lesion length. IVUS is employed to obtain detailed images of the vessel wall, helping to visualize the morphology of the treated segment and assess the presence of any complications such as stent malapposition or edge dissections. OCT, with its high resolution, allows for detailed imaging of the coronary artery, providing information on plaque composition and stent apposition.
By combining these invasive imaging tools with clinical follow-ups at specified intervals, the study aims to provide a comprehensive evaluation of the long-term efficacy and safety of bioresorbable scaffold implantation in the treatment of chronic total coronary occlusion. The focus on target lesion failure as the primary outcome measure ensures a clinically relevant assessment of the success of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group consists of study participants who where treated for chronic total coronary occlusion with bioresorbable scaffolds
| Arm | Type | Receives |
|---|---|---|
| Chronic total coronary occlusion | Other | Procedure: Percutaneous coronary intervention.Participants who underwent percutaneous coronary intervention for chronic total coronary occlusion revascularization with bioresorbable scaffold. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 100% occlusion of a coronary artery for a duration of greater than or equal to 3 months based on angiographic evidence.
Key exclusion criteria (1 listed)
- Participant withdrawal from study.
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 |
|---|---|---|
| Percutaneous coronary intervention.Revascularization of chronic total coronary occlusion. | Procedure or surgery | Chronic total coronary occlusion |
Primary outcome
Target Lesion Failure
Time frame: 6 years
Target Lesion Failure (TLF) will be assessed as the number of participants experiencing at least one of the following events during the follow-up period: cardiovascular death, clinically driven target lesion revascularization, target vessel myocardial infarction and stent thrombosis according to the Academic Research Consortium.
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 11 Jun 2025.
Related trials for Angina Pectoris
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
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?
A study testing Percutaneous coronary intervention. in people with Angina Pectoris and Coronary Artery Disease, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
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 1 inclusion and 1 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 11 Jun 2025. 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 Latvia. 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?
Target Lesion Failure (time frame: 6 years). 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 11 Jun 2025.