Coronary Heart DiseaseHealingNCT04465669
Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
A study testing Orsiro stents and Resolute Integrity® stents in people with Coronary Heart Disease and Stable Angina Pectoris, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
The objective of this study is a comparative evaluation of Orsiro stent and of Resolute Integrity stent in terms of the extent of neointima formation at 4 months after implantation using optical coherence tomography (OCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Stable Angina Pectoris, Silent Myocardial Ischemia
- What is being tested?
- Orsiro stents and Resolute Integrity® stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 13 Jan 2020to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years;
- Patients with symptoms of stable angina and/or presence of a positive functional test for ischemia;
- Patient is eligible for percutaneous coronary intervention (PCI);
- Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.
Who cannot join
- Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter;
- Target lesion located in the left main stem;
- Target lesion is located or supplied by an arterial or venous bypass graft;
- Lesion located very distally, difficult to be imaged by OCT;
- Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
- Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
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- Patient underwent target vessel revascularization with a DES;
- Patient presenting with acute myocardial infarction with ST elevation;
- Cerebrovascular accident within the past 12 months;
- Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
- Patient receiving oral anticoagulants
Trial locations and contacts
1 site in 1 country.
Russia1 site
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Tyumen, 625026
About this study
The objective of this study is a comparative evaluation of Orsiro stent and of Resolute Integrity stent in terms of the extent of neointima formation at 4 months after implantation using optical coherence tomography (OCT).
Read the detailed description
About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).
All of the patients will receive 12 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 1 year. The follow-up visits will be conducted at 4 months (including angiographic/OCT investigation), and 1 year post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
- Being tested
- Orsiro stents, Resolute Integrity® stents
- Medical subject headings
- Coronary Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orsiro stentsDevice
Percutaneous coronary intervention with implantation of either:
a Orsiro® biolimus a9 eluting coronary stent
Resolute Integrity® stentsDevice
Percutaneous coronary intervention with implantation of either:
a Resolute Integrity® zotarolimus eluting coronary stent
| Study group | Role | What they receive |
|---|---|---|
| Orsiro | Active comparator | Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES) Receives: Device: Orsiro stents |
| Resolute Integrity | Active comparator | Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES) Receives: Device: Resolute Integrity® stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heterogeneous neointimal healing
Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography
Measured: 4 ± 1 months
Secondary outcomes (10)
Malapposed stent struts
Percentage of malapposed stent struts by optical coherence tomography
Measured: 4 ± 1 months
Neointimal growth
Neointimal thickness by optical coherence tomography
Measured: 4 ± 1 months
Angiographic reference vessel diameter
Reference diameter of coronary artery by QCA
Measured: 4 ± 1 months
Clinical composite endpoints
Cardiac death/Target vessel MI/Clinically indicated TLR All death/All MI/All TVR (including TLR)
Measured: 12 months
Stent Thrombosis
Definite stent thrombosis
Measured: 12 months
Uncovered stent struts
Percentage of uncovered stent struts by optical coherence tomography
Measured: 4 ± 1 months
Angiographic minimal lumen diameter
Minimal lumen diameter of coronary artery by QCA;
Measured: 4 ± 1 months
Angiographic diameter stenosis
Percent diameter stenosis by QCA;
Measured: 4 ± 1 months
Binary restenosis
Binary restenosis by QCA;
Measured: 4 ± 1 months
Angiographic late lumen loss
Late lumen loss by QCA;
Measured: 4 ± 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start13 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bessonov S Ivan, Principal investigator, Tyumen Cardiology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465669
- Sponsor's protocol ID
- TCRC-144a
- Acronym
- Healing
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2020
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
- ClinicalTrials.gov ID
- NCT04465669
- Acronym / sponsor ID
- Healing / TCRC-144a
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Jul 2020 (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 study is a comparative evaluation of Orsiro stent and of Resolute Integrity stent in terms of the extent of neointima formation at 4 months after implantation using optical coherence tomography (OCT).
Detailed description
About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).
All of the patients will receive 12 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 1 year. The follow-up visits will be conducted at 4 months (including angiographic/OCT investigation), and 1 year post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).
| Arm | Type | Receives |
|---|---|---|
| Orsiro | Active comparator | Device: Orsiro stentsImplantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES) |
| Resolute Integrity | Active comparator | Device: Resolute Integrity® stentsImplantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years;
- Patients with symptoms of stable angina and/or presence of a positive functional test for ischemia;
- Patient is eligible for percutaneous coronary intervention (PCI);
- Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.
Key exclusion criteria (11 listed)
- Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter;
- Target lesion located in the left main stem;
- Target lesion is located or supplied by an arterial or venous bypass graft;
- Lesion located very distally, difficult to be imaged by OCT;
- Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
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 |
|---|---|---|
| Orsiro stentsPercutaneous coronary intervention with implantation of either: a Orsiro® biolimus a9 eluting coronary stent | Device | Orsiro |
| Resolute Integrity® stentsPercutaneous coronary intervention with implantation of either: a Resolute Integrity® zotarolimus eluting coronary stent | Device | Resolute Integrity |
Primary outcome
Heterogeneous neointimal healing
Time frame: 4 ± 1 months
Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography
10 secondary outcomes
Malapposed stent struts
Time frame: 4 ± 1 months
Neointimal growth
Time frame: 4 ± 1 months
Angiographic reference vessel diameter
Time frame: 4 ± 1 months
Clinical composite endpoints
Time frame: 12 months
Stent Thrombosis
Time frame: 12 months
Uncovered stent struts
Time frame: 4 ± 1 months
Angiographic minimal lumen diameter
Time frame: 4 ± 1 months
Angiographic diameter stenosis
Time frame: 4 ± 1 months
Binary restenosis
Time frame: 4 ± 1 months
Angiographic late lumen loss
Time frame: 4 ± 1 months
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 24 Jun 2026.
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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.
Bessonov S Ivan principal investigator
Tyumen Cardiology Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orsiro stents and Resolute Integrity® stents in people with Coronary Heart Disease and Stable Angina Pectoris, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
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 11 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 24 Jun 2026. 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 Russia. 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?
Heterogeneous neointimal healing (time frame: 4 ± 1 months). 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 24 Jun 2026.