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AzTrials

Coronary Artery DiseaseHREVSNCT01699048

The Comparative Effectiveness of Hybrid Revascularization (MIDCAB Then PCI) With DES Versus Multivessel DES PCI or CABG

A study testing Hybrid (MIDCAB+PCI), PCI and CABG in people with Coronary Artery Disease and Myocardial Ischemia, run by Russian Academy of Medical Sciences at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Minimally invasive revascularization of the left anterior descending artery followed by stent implantation versus percutaneous coronary intervention or coronary artery bypass in patients with multi-vessel coronary disease Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Hybrid (MIDCAB+PCI), PCI and CABG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteRussia
Study dates
1 Dec 2012to 16 Sep 2017
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

  • Multi-vessel coronary artery disease with ≥ 70% and <96% artery stenosis (according to QCA)
  • I-IV CCS functional class of angina
  • Asymptomatic patients with stress-test documented ischemia.
  • Patients at 1 month after acute myocardial infarction
  • Ability to perform either of revascularization methods (Hybrid, MVD-PCI, CABG).
  • Consensus on the treatment strategy between the members of the working group, including cardiologist, cardiac surgeon and interventional specialist.
  • Patients must have signed an informed consent.

Who cannot join

  • Pregnancy.
  • Acute coronary syndrome.
  • Previous CABG.
  • Previous stent thrombosis.
  • Severe comorbidity with high procedural risk for either of the studied strategies.
  • Severe peripheral artery disease.
Show all 16Show fewer
  • Other serious diseases limiting life expectancy (e.g. oncology)
  • Inability for long-term follow-up.
  • Participation in other clinical trials.
  • Inability to take dual antithrombotic therapy.
  • Angiographic exclusion criteria
  • Critical stenosis (>95%) in RCA,LAD, CX or Intermediate artery, feasible for revascularization.
  • Stenosis of left main ≥ 50%.
  • Coronary artery occlusion of the major vessel.
  • Single vessel disease.
  • Need for emergency revascularization (ACS).

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Research Institute of Complex Issues of Cardiovascular Diseases

    Kemerovo, Kemerovo Oblast, 650002

Other trials in Russia

About this study

Official title: Prospective, Single-center, Randomized Trial, Intended to Compare Three Revascularization Strategies in Patients With Multi-vessel Coronary Artery Disease

Minimally invasive revascularization of the left anterior descending artery followed by stent implantation versus percutaneous coronary intervention or coronary artery bypass in patients with multi-vessel coronary disease

Read the detailed description

Prospective, single-center, randomized trial, intended to compare three revascularization strategies in patients with multi-vessel coronary artery disease:

  1. Hybrid approach (Minimally invasive off-pump revascularization of the left anterior descending artery (LAD) with left internal mammary artery (LIMA) bypass followed by consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with drug eluting stents (DES) (Hybrid group, n=50)
  2. Multi-vessel PCI with DES (MV-PCI group, n=50)
  3. Coronary artery bypass graft (CABG) treatment (CABG group, n=50)

PCI in Hybrid and MV-PCI group will be performed with the same 2nd generation clinically proven DES (Xience V, Xience Prime).

Study objective Compare three different revascularization strategies in patients with multi-vessel coronary disease

The endpoints:

The primary endpoints:

  1. % ischemic myocardium on a 12-month follow-up scan with single photon emission computed tomography (SPECT);

The secondary endpoints:

  1. Major adverse cardiac and cerebral events (MACCE), including (1) death, (2) non-fatal myocardial infarction (non-fatal MI), transitory ischemic attack (TIA) or stroke within 30 days, 12 months and 5-year follow-up; II. Target vessel/graft failure (for any of the target vessels in a given patient - stented or grafted) = a composite of cardiac death, MI attributable to the target vessel, or clinically-driven [ie, not angio-driven] Target Vessel Revascularization (TVR); III. Restenosis = angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%; IV. Procedural success: The treatment will be considered successful when a revascularisation in the absence of complications during the index hospitalization has been achieved; V. Procedural and post-procedural hemorrhagic complications [ Time Frame: up to discharge from the hospital ]; VI. Recovery time [ Time Frame: up to discharge from the hospital ];
Being tested
Hybrid (MIDCAB+PCI), PCI, CABG
Keywords
multivessel PCI,MIDCAB,CABG, Hybrid coronary revascularization
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hybrid (MIDCAB+PCI)Procedure or surgery

    Also called MIDCAB

    Hybrid approach (Minimally invasive of-pump revascularization of the left anterior descending artery (LAD) via left internal mammary artery (LIMA) bypass with consecutive percutaneous coronary intervention (PCI) in the rest arteries with drug eluting stents (DES). The revascularization will be performed in two stages within a 3-days interval

  • PCIProcedure or surgery

    Multi-vessel PCI with DES

  • CABGProcedure or surgery

    Coronary artery bypass graft (CABG) treatment

Study groups in NCT01699048
Study groupRoleWhat they receive
Hybrid groupOtherHybrid approach (Minimally invasive off-pump revascularization of the left anterior descending artery (LAD) with the left internal mammary artery (LIMA) bypass followed by consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with drug eluting stents (DES) (Hybrid group, n=50)
Receives: Procedure: Hybrid (MIDCAB+PCI)
PCIOtherMulti-vessel PCI with DES (MV-PCI group, n=50)
Receives: Procedure: PCI
CABGOtherCoronary artery bypass graft (CABG) treatment (CABG group, n=50)
Receives: Procedure: CABG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Residual ischemia

    ≥5% residual ischemia by single photon emission computed tomography (SPECT)

    Measured: 6 - to 18-month follow-up

Secondary outcomes (6)

  1. MACCE

    Major adverse cardiac and cerebral events (MACCE), including death,a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events:

    Death from any cause From cardiovascular causes From noncardiovascular causes Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG.

    Measured: up to 5 years

  2. Procedural success

    Procedural success: The treatment will be considered successful when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved.

    Measured: up to discharge from the hospital

  3. Procedural and post-procedural blood loss and number of transfusions

    dynamics of hemoglobin at admission and discharge, the number of blood transfusions (in units), classification of bleeding BARC

    Measured: up to discharge from the hospital

  4. Recovery time

    Time Frame: from the end of the intervention up to discharge from the hospital. Total duration of hospital admission

    Measured: up to discharge from the hospital

  5. Target vessel/graft failure

    (for any of the target vessels in a given patient - stented or grafted) = a composite of cardiac death, MI attributable to the target vessel, or clinically-driven [ie, not angio-driven] Target Vessel Revascularization (TVR);

    Measured: 6- to 18-month follow-up

  6. Restenosis

    angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%;

    Measured: 6- to 18-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2012 (estimated)
  2. Study start1 Dec 2012
  3. Primary completion1 Mar 2017
  4. Study completion16 Sep 2017

Resources

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
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01699048
Sponsor's protocol ID
HREVS
Acronym
HREVS
Status last verified
Sep 2017
First submitted
1 Oct 2012
Last updated
29 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • Ganyukov VI, Kochergin NA, Shilov AA, Tarasov RS, Skupien J, Kozyrin KA, Barbarash OL, Musialek P. Randomized Clinical Trial of Surgical Versus Percutaneous Versus Hybrid Multivessel Coronary Revascularization: 3 Years' Follow-Up. JACC Cardiovasc Interv. 2021 May 24;14(10):1163-1165. doi: 10.1016/j.jcin.2021.02.037. No abstract available.

    PubMed 34016423

  • Ganyukov V, Kochergin N, Shilov A, Tarasov R, Skupien J, Szot W, Kokov A, Popov V, Kozyrin K, Barbarash O, Barbarash L, Musialek P. Randomized Clinical Trial of Surgical vs. Percutaneous vs. Hybrid Revascularization in Multivessel Coronary Artery Disease: Residual Myocardial Ischemia and Clinical Outcomes at One Year-Hybrid coronary REvascularization Versus Stenting or Surgery (HREVS). J Interv Cardiol. 2020 Jan 3;2020:5458064. doi: 10.1155/2020/5458064. eCollection 2020.

    PubMed 31969796

Questions about this trial

What is this clinical trial studying?

A study testing Hybrid (MIDCAB+PCI), PCI and CABG in people with Coronary Artery Disease and Myocardial Ischemia, run by Russian Academy of Medical 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 7 inclusion and 16 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 29 Sep 2017. 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?

Residual ischemia (time frame: 6 - to 18-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01699048, which also lists 2 linked publications.

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 29 Sep 2017.

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