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Coronary Artery DiseasePhase 4NCT01515228

Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)

A Phase 4 study testing Xience Prime and Cilotax stent in people with Coronary Artery Disease, run by CHEOL WHAN LEE, MD, PhD. at 9 sites in South Korea.

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

The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients. Read more about this study

Who is it for?
Ages 21 to 74 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Xience Prime and Cilotax stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
291 participants
Where
9 sitesSouth Korea
Study dates
Jan 2012to Jan 2015
Phase
Phase 4
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 21 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical:
  • Diabetic patients with active treatment (oral agent or insulin)
  • Patients with angina and documented ischemia or patients with documented silent ischemia
  • Patients who are eligible for intracoronary stenting
  • Age > 20 years, < 75 years
  • Angiographic:
Show all 9Show fewer
  • De novo lesion
  • Percent diameter stenosis ≥ 50%
  • Reference vessel size ≥ 2.5 mm by visual estimation

Who cannot join

  • History of bleeding diathesis or coagulopathy
  • Pregnant state
  • Known hypersensitivity or contra-indication to contrast agent and heparin
  • Limited life-expectancy (less than 1 year)
  • ST-elevation acute myocardial infraction requiring primary stenting
  • Characteristics of lesion: left main disease, in-stent restenosis, graft vessels
Show all 14Show fewer
  • Hematological disease (Neutropenia < 3000/mm3), Thrombocytopenia < 100,000/mm3)
  • Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3times normal
  • Renal dysfunction, creatinine ≥ 2.0mg/dL
  • Contraindication to aspirin, clopidogrel or cilostazol
  • Contraindication to Paclitaxel or everolimus
  • Left ventricular ejection fraction < 30%
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
  • Non-cardiac co-morbid conditions are present with life expectancy < 1 year or that may result in protocol non-compliance (per site investigator's medical judgment for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan

  • Daegu Catholic University Medical Center

    Daegu

  • Keimyung University Dongsan Medical Center

    Daegu

  • Chungnam National University Hospital

    Daejeon

  • The Catholic University of Korea, Daejeon ST. Mary's Hospital

    Daejeon

  • Gangneung Asan Hospital

    Gangneung

  • Inje University Pusan Paik Hospital

    Pusan

  • Asan Medical Center

    Seoul

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

Official title: Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.

Read the detailed description

Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.

Being tested
Xience Prime, Cilotax stent
Keywords
requiring drug eluting stents
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Xience PrimeDevice

    Also called everolimus-eluting stent

    everolimus-eluting stent implantation

  • Cilotax stentDevice

    Also called paclitaxel with cilostazol dual drug eluting stent

    paclitaxel with cilostazol dual drug eluting stent implantation

Study groups in NCT01515228
Study groupRoleWhat they receive
Xience Prime stentActive comparatoreverolimus eluting stent
Receives: Device: Cilotax stent
Cilotax stentExperimentalpaclitaxel with cilostazol dual drug eluting stent
Receives: Device: Xience Prime

What is being measured

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

  1. In-segment late luminal loss

    Measured: at 9 month angiographic follow-up

Secondary outcomes (27)

  1. All Death

    Measured: 12 months

  2. Cardiac death

    Measured: 12 months

  3. Myocardial infarction

    Measured: 12 months

  4. Target vessel revascularization (ischemia-driven)

    Measured: 12 months

  5. Target lesion revascularization (ischemia-driven)

    Measured: 12 months

  6. Stent thrombosis (by ARC definition)

    Measured: 12 months

  7. Binary restenosis in both in-stent and in-segment

    Measured: at 9 month angiographic follow-up

  8. Angiographic pattern of restenosis

    Measured: at 9 month angiographic follow-up

  9. Procedural success

    achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay

    Measured: At discharge from the index hospitalization, an expected average of 3 days.

  10. All Death

    Measured: 1 month

  11. All Death

    Measured: 4 months

  12. All Death

    Measured: 9 months

  13. Cardiac death

    Measured: 1 month

  14. Cardiac death

    Measured: 4 months

  15. Cardiac death

    Measured: 9 months

  16. Myocardial infarction

    Measured: 1 month

  17. Myocardial infarction

    Measured: 4 months

  18. Myocardial infarction

    Measured: 9 months

  19. Target vessel revascularization (ischemia-driven)

    Measured: 1 month

  20. Target vessel revascularization (ischemia-driven)

    Measured: 4 months

  21. Target vessel revascularization (ischemia-driven)

    Measured: 9 months

  22. Target lesion revascularization (ischemia-driven)

    Measured: 1 month

  23. Target lesion revascularization (ischemia-driven)

    Measured: 4 months

  24. Target lesion revascularization (ischemia-driven)

    Measured: 9 months

  25. Stent thrombosis (by ARC definition)

    Measured: 1 month

  26. Stent thrombosis (by ARC definition)

    Measured: 4 months

  27. Stent thrombosis (by ARC definition)

    Measured: 9 months

Timeline

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

  1. First posted24 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2014
  4. Study completionJan 2015

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01515228
Sponsor's protocol ID
CVRF2011-11
Status last verified
Jan 2015
First submitted
18 Jan 2012
Last updated
9 Jan 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Xience Prime and Cilotax stent in people with Coronary Artery Disease, run by CHEOL WHAN LEE, MD, PhD. at 9 sites in South Korea.

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 9 inclusion and 14 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 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Korea. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

In-segment late luminal loss (time frame: at 9 month angiographic 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 NCT01515228.

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 9 Jan 2015.

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