Ischemic Heart DiseaseNCT02708329
T-provisional Stenting vs Mini-Crush in Chronic Total Occlusions (CTO)
A study testing T-provisional stenting, Mini-crush stenting and CTO coronary angioplasty in people with Ischemic Heart Disease and Coronary Atherosclerosis, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques in patients with bifurcation lesions in the CTO segment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease
- What is being tested?
- T-provisional stenting, Mini-crush stenting and CTO coronary angioplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2011to Dec 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction).
- Bifurcation side branch diameter >2 mm in CTO segment, verified by coronary angiography
- Successful CTO recanalization
- Signed, documented informed consent prior to admission to the study
Who cannot join
- Age <18 years or >75 years
- Left main artery bifurcation lesion
- Reocclusion CTOs
- Renal insufficiency (GFR/MDRD <30 ml/min)
- Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
- Known non-adherence to double anti-platelet therapy (DAPT)
Show all 11Show fewer
- LVEF <30%
- Continuing bleeding
- Acute coronary syndrome (ST-elevation Myocardial infarction)
- Anamnesis of previous CABG
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Institute of CIrculation Pathology
Novosibirsk, 630055
About this study
Official title: Results of T-provisional and Mini Crush Stenting in Patients With Bifurcation Lesions After Chronic Coronary Arteries Occlusions Recanalization: A Prospective Randomized Single-center Study.
The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques in patients with bifurcation lesions in the CTO segment.
- Conditions
- Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease, Coronary Artery Stenosis
- Being tested
- T-provisional stenting, Mini-crush stenting, CTO coronary angioplasty
- Keywords
- Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Bifurcational lesion, Bifurcational stenting
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-provisional stentingProcedure or surgery
Standard endovascular T-provisional stenting technique
Mini-crush stentingProcedure or surgery
Standard endovascular Mini-crush stenting technique
CTO coronary angioplastyProcedure or surgery
A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.
| Study group | Role | What they receive |
|---|---|---|
| CTO coronary angioplasty +T-provisional stenting | Active comparator | Coronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment. Receives: Procedure: T-provisional stenting; Procedure: CTO coronary angioplasty |
| CTO coronary angioplasty + Mini-crush stenting | Experimental | Coronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment. Receives: Procedure: Mini-crush stenting; Procedure: CTO coronary angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.
Measured: During 1 year after procedure
Secondary outcomes (2)
Major adverse cardiac and cerebrovascular events (MACCE)
Major adverse cardiac and cerebrovascular events (MACCE) including: including: All-cause mortality, Myocardial infarction, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization.
Measured: During 1 year after procedure
Restenosis of main vessel/side branch
Angiographically estimated main vessel/side branch restenosis. Restenosis is defined as ≥ 50% diameter lumen loss in a target lesion.
Measured: At 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708329
- Sponsor's protocol ID
- TvsMC 1.0
- Status last verified
- May 2016
- First submitted
- 9 Mar 2016
- Last updated
- 10 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of T-provisional and Mini Crush Stenting in Patients With Bifurcation Lesions After Chronic Coronary Arteries Occlusions Recanalization: A Prospective Randomized Single-center Study.
- ClinicalTrials.gov ID
- NCT02708329
- Acronym / sponsor ID
- TvsMC 1.0
- Conditions
- Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease, Coronary Artery Stenosis
- Keywords
- Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Bifurcational lesion, Bifurcational stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Mar 2016 (estimated)
- 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 is to compare the results of using T-provisional and Mini-Crush stenting techniques in patients with bifurcation lesions in the CTO segment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTO coronary angioplasty +T-provisional stenting | Active comparator | Procedure: T-provisional stenting, Procedure: CTO coronary angioplastyCoronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment. |
| CTO coronary angioplasty + Mini-crush stenting | Experimental | Procedure: Mini-crush stenting, Procedure: CTO coronary angioplastyCoronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction).
- Bifurcation side branch diameter >2 mm in CTO segment, verified by coronary angiography
- Successful CTO recanalization
- Signed, documented informed consent prior to admission to the study
Key exclusion criteria (11 listed)
- Age <18 years or >75 years
- Left main artery bifurcation lesion
- Reocclusion CTOs
- Renal insufficiency (GFR/MDRD <30 ml/min)
- Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
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 |
|---|---|---|
| T-provisional stentingStandard endovascular T-provisional stenting technique | Procedure or surgery | CTO coronary angioplasty +T-provisional stenting |
| Mini-crush stentingStandard endovascular Mini-crush stenting technique | Procedure or surgery | CTO coronary angioplasty + Mini-crush stenting |
| CTO coronary angioplastyA standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months. | Procedure or surgery | CTO coronary angioplasty + Mini-crush stenting, CTO coronary angioplasty +T-provisional stenting |
Primary outcome
Target lesion failure
Time frame: During 1 year after procedure
Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.
2 secondary outcomes
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: During 1 year after procedure
Restenosis of main vessel/side branch
Time frame: At 12-month follow-up
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 10 May 2016.
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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?
A study testing T-provisional stenting, Mini-crush stenting and CTO coronary angioplasty in people with Ischemic Heart Disease and Coronary Atherosclerosis, run by Meshalkin Research Institute of Pathology of Circulation 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 10 May 2016. 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?
Target lesion failure (time frame: During 1 year after 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 10 May 2016.