AzTrials
AzTrials

Ischemic Heart DiseaseNCT03401216

StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation

A study testing SYNERGY 48 mm, PCI and 3 month OCT follow-up in people with Ischemic Heart Disease and Coronary Artery Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The objective of this study is to evaluate the rate of SYNERGY 48 mm stent strut coverage and assess neointimal progression via OCT measurement in patients who underwent PCI. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SYNERGY 48 mm, PCI and 3 month OCT follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteRussia
Study dates
20 Mar 2017to 30 Apr 2019
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

  • Signed written informed consent before study procedures
  • Subject is eligible for percutaneous coronary intervention (PCI)
  • Left ventricular ejection fraction (LVEF) >30%
  • Reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
  • Target lesion(s) length must be ≥38 mm
  • Target lesion(s) stenosis ≥50%

Who cannot join

  • History of acute or recent stroke (<2 months)
  • Contraindications for antiplatelet and/or anticoagulant therapy
  • Bleeding within the last 30 days
  • Subject has acute ST elevation MI (STEMI)
  • Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support
  • Subject with out of range complete blood count (CBC) values determined as a clinically significant
Show all 13Show fewer
  • Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
  • Subject has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
  • Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure
  • Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
  • Lesion located within a saphenous vein graft or an arterial graft
  • Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
  • Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months

Trial locations and contacts

1 site in 1 country.

Aleksei Prokhorikhin, MD contact

+79137178040

turbogold@list.ru

Russia1 site, 1 recruiting

  • Academician E.N. Meshalkin national medical research center

    Novosibirsk, 630055

    Evgeny Kretov, MD, PhD, +79137906533, sibvolna2005@yandex.ru

    Evgeny Kretov, MD, PhD

    Recruiting

Other trials in Russia

About this study

Official title: StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation: Prospective sTudy Using optIcal cOhereNce Tomography

The objective of this study is to evaluate the rate of SYNERGY 48 mm stent strut coverage and assess neointimal progression via OCT measurement in patients who underwent PCI.

Read the detailed description

Patients with stable, unstable angina and non-ST-elevation ACS will be included in this study. Patient will undergo coronary angiography for coronary anatomy assessment and estimation indications for PCI . After screening an OCT-guided PCI with extra long SYNERGY stent implantation will be provided in all patients. Patient will be divided into 2 groups of follow-up and will be followed within 3 and 6 month after procedure. Final clinical follow-up will be assessed at 12 month for all patients. At each follow-up visits the data regarding clinical events, coronary angiography and OCT-imaging will be collected.

Being tested
SYNERGY 48 mm, PCI, 3 month OCT follow-up, 6 month OCT follow-up
Keywords
Optical coherence tomography, Healing score, Neointimal coverage, synergy 48, long lesion
Medical subject headings
Myocardial Ischemia, Coronary Artery Disease

What participants receive

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

  • SYNERGY 48 mmDevice

    Material: Platinum-Chromium alloy. Stent strut thickness: 0.0029-0.0032 inches. Polymer carrier composed of PLGA (poly(DL-lactide-co-glycolide)). Drug product: Everolimus, 1µg per 1 mm2. Stent diameters available: 2.25; 2.50; 2.75; 3.00; 3.50; 4.00 mm. Stent length: 48 mm. Nominal balloon pressure: 11 atm. (1117 kPa). Manufacturing company: Boston Scientific Corporation (USA)

  • PCIProcedure or surgery

    Standard PCI procedure

  • 3 month OCT follow-upProcedure or surgery

    Optical coherence tomography imaging of target vessel within 3 month after PCI

  • 6 month OCT follow-upProcedure or surgery

    Optical coherence tomography imaging of target vessel within 5 month after PCI

Study groups in NCT03401216
Study groupRoleWhat they receive
SYNERGY 48 PCI + 3 month OCT follow-upExperimentalSynergy 48 mm stent implantation followed by 3 month OCT imaging
Receives: Device: SYNERGY 48 mm; Procedure: PCI; Procedure: 3 month OCT follow-up
SYNERGY 48 PCI + 6 month OCT follow-upExperimentalSynergy 48 mm stent implantation followed by 6 month OCT imaging
Receives: Device: SYNERGY 48 mm; Procedure: PCI; Procedure: 6 month OCT follow-up

What is being measured

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

  1. Neointimal healing score

    The neointimal healing score is based on four stent-related characteristics and is calculated on a lesion level:

    • Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of "4".
    • Presence of both malapposed and uncovered struts (% malapposed/ uncovered, MU) is assigned a weight of "3"
    • Presence of uncovered struts alone (% malapposed, M) is assigned a weight of "2"
    • Presence of malapposed struts alone (% uncovered, U) is assigned a weight of "1"

    Measured: within 3 month after PCI

  2. Neointimal healing score

    The neointimal healing score is based on four stent-related characteristics and is calculated on a lesion level:

    • Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of "4".
    • Presence of both malapposed and uncovered struts (% malapposed/ uncovered, MU) is assigned a weight of "3"
    • Presence of uncovered struts alone (% malapposed, M) is assigned a weight of "2"
    • Presence of malapposed struts alone (% uncovered, U) is assigned a weight of "1"

    Measured: within 6 month after PCI

Secondary outcomes (4)

  1. Percentage of strut coverage assessed by OCT

    In metallic DES, the struts are classified as covered in the presence of a coverage thickness >0 μm (tissue can be identified above the struts).

    Measured: within 3 month after PCI

  2. Percentage of strut coverage assessed by OCT

    In metallic DES, the struts are classified as covered in the presence of a coverage thickness >0 μm (tissue can be identified above the struts).

    Measured: within 6 month after PCI

  3. Percentage of mature neointimal tissue assessed by OCT

    To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.

    Measured: within 3 month after PCI

  4. Percentage of mature neointimal tissue assessed by OCT

    To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.

    Measured: within 6 month after PCI

Timeline

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

  1. First posted17 Jan 2018
  2. Study start20 Mar 2017
  3. Primary completion30 Apr 2018 (estimated)
  4. Study completion30 Apr 2019 (estimated)

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
Model description
80 patients, that underwent PCI with Synergy 48 mm stent implantation, will be randomized into 2 groups of follow-up OCT-visualization - 3 and 6 month.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03401216
Sponsor's protocol ID
Exeption
Status last verified
Jan 2018
First submitted
25 Dec 2017
Last updated
17 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing SYNERGY 48 mm, PCI and 3 month OCT follow-up in people with Ischemic Heart Disease and Coronary Artery Disease, 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 Jan 2018. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Aleksei Prokhorikhin, MD (+79137178040, turbogold@list.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neointimal healing score (time frame: within 3 month after PCI). The study lists 2 primary outcomes in all. 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 NCT03401216.

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 17 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in