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Coronary Artery LesionsPhase 2REMEDEENCT00967902

Safety and Effectiveness Study of Combo Bio-engineered Sirolimus Eluting Stent

A Phase 2 study testing coronary stenting in people with Coronary Artery Lesions, run by OrbusNeich at 1 site in Australia.

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

To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery lesions. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Lesions
What is being tested?
coronary stenting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteAustralia
Study dates
Nov 2009to Sep 2015
Phase
Phase 2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria
  • The patient must be ≥18 and ≤ 80 years of age;
  • Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC, IIIB, IIIC, and/or objective evidence of myocardial ischemia);
  • Acceptable candidate for CABG;
  • The Patient is willing to comply with specified follow-up evaluations;
  • The Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC).
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  • Angiographic Inclusion Criteria:
  • Single de novo or non-stented restenotic lesion in the target vessel;
  • Patients with two-vessel coronary disease, may have undergone successful treatment (<20% diameter stenosis by visual estimate) of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment. Any non-target vessel or lesion intended to be treated during the index procedure, cannot be an unprotected left main, ostial lesion, chronic total occlusion (CTO), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty;
  • Target lesion located in a native coronary artery;
  • Target lesion (maximum length is 20 mm by visual estimate) covered by a single stent maximum 23 mm length for Combo Stent, and 24 mm in length for TAXUS® Liberté® (stent coverage including at least 3 mm of healthy vessel is recommended). The lesion length should be measured after pre-dilation procedure;
  • Reference vessel diameter must be ≥2.5 to ≤ 3.5 mm by visual estimate. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected;
  • Target lesion ≥50% and <100% stenosed by visual estimate.

Who cannot join

  • General Exclusion Criteria:
  • Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
  • Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (elevated troponin or CK-MB ≥2 times upper limit of normal) or >72 hours preceding the index procedure and CK and CK-MB have not returned to within normal limits at the time of procedure;
  • The patient is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate unresponsive prolonged chest pain;
  • Impaired renal function (serum creatinine >2.0 mg/dL or 177 μmol/l) or on dialysis;
  • Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3;
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  • Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated;
  • Patient requires low molecular weight heparin (LMWH) treatment post-procedure or has received a dose of LMWH ≤8 hours prior to index procedure;
  • Patient has received any organ transplant or is on a waiting list for any organ transplant;
  • Patient has other medical illness (e.g., cancer, known malignancy, or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
  • Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus, paclitaxel and/or contrast sensitivity that cannot be adequately pre-medicated;
  • Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA);
  • Patient presents with cardiogenic shock;
  • Patient has current unstable cardiac arrhythmias that create hemodynamic instability;
  • Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion;
  • Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
  • Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up;
  • Angiographic Exclusion Criteria:
  • Unprotected left main coronary artery disease with ≥50% stenosis;
  • Ostial target lesion(s);
  • Totally occluded target vessel (TIMI flow 0);
  • Calcified target lesion(s) which cannot be successfully predilated;
  • Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
  • Angiographic evidence of thrombus in the target lesion(s);
  • Target lesion involving bifurcation with a side branch ≥2.0 mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require intervention of diseased side branch;
  • A significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single stent;
  • Diffuse distal disease to target lesion with impaired runoff;
  • Left ventricular ejection fraction (LVEF) ≤30% (LVEF must be obtained within 6 months prior to the index procedure);
  • Pre-treatment with devices other than balloon angioplasty;
  • Prior stent within 10 mm of target lesion;
  • Intervention (PCI or bypass) of another lesion performed within 6 months before or planned within 30 days following the index procedure.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • John Hunter Hospital

    Newcastle, New South Wales, 2300

Other trials in Australia

About this study

Official title: The REMEDEE Study: A Prospective, Randomized Study to Evaluate the Safety and Efficacy of an Abluminal Sirolimus Coated Bio-engineered Stent (Combo Bio-engineered Sirolimus Eluting Stent)

To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery lesions.

Being tested
coronary stenting
Keywords
intracoronary stent, drug eluting stent, sirolimus, endothelial progenitor cells

What participants receive

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

  • coronary stentingDevice

    Balloon dilatation of obstructive coronary artery disease with deployment of a metallic stent to scaffold the dilated lesion; stent incorporating sustained release of anti-proliferative agent to control neointimal proliferation and reocclusion; test device incorporates affinity surface for circulating EPCs

Study groups in NCT00967902
Study groupRoleWhat they receive
ComboExperimentalThe Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.
Receives: Device: coronary stenting
Taxus® Liberté® StentActive comparatorCommercially available product
Receives: Device: coronary stenting

What is being measured

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

  1. In-stent late lumen loss of the Combo Stent compared to the TAXUS® Liberté® DES

    Measured: 9 months post-procedure.

Secondary outcomes (16)

  1. All-cause and cardiac mortality

    Measured: 30 days, 9 months, 1, 2, 3, 4, and 5 year

  2. Myocardial infarction: Q-wave and non Q-wave, cumulative and individual

    Measured: 30 days, 9 months, 1, 2, 3, 4, and 5 years

  3. Major Adverse Cardiac Event (MACE) defined as a composite of death, MI (Q-wave or non Q-wave), emergent CABG, or target lesion revascularization by repeat PTCA or CABG

    Measured: Hospital discharge, 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure

  4. Vascular complications from index procedure

    Measured: Up to hospital discharge

  5. Rate of stent thrombosis, per ARC definition of definite and probable stent thrombosis further categorized as early, late or very late

    Measured: 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure

  6. Change in human anti-murine antibody (HAMA) plasma levels

    Measured: 30 day and 9 month follow-up compared to baseline

  7. Device success, defined as attainment of <50% residual stenosis of the target lesion using the Combo Stent

    Measured: Index procedure

  8. Lesion success defined as attainment of < 50% residual stenosis using any percutaneous method

    Measured: Index procedure

  9. Procedure success defined as lesion success without the occurrence of in-hospital MACE

    Measured: Up to hospital discharge

  10. Clinically (ischemia)-driven target lesion revascularization

    Measured: 30 days, 9 months, 1, 2, 3, 4 and 5 years

  11. Clinically (ischemia)-driven target vessel revascularization

    Measured: 30 days, 9 months, 1, 2, 3, 4 and 5 years

  12. In-stent and in-segment angiographic binary restenosis

    Measured: 9 months

  13. In-stent and in-segment minimum lumen diameter (MLD)

    Measured: 9 months

  14. In-stent, proximal and distal late lumen loss

    Measured: 9 months

  15. Neointimal hyperplasia volume and % in-stent volume obstruction as measured by intravascular ultrasound (IVUS) for patients receiving angiographic/IVUS follow-up

    Measured: 9 months

  16. Target lesion failure (TLF) (defined as death, MI and ischemic target lesion revascularization (TLR))

    Measured: 30 days, 9 months, 1, 2, 3, 4 and 5 years

Timeline

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

  1. First posted28 Aug 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionJul 2011
  4. Study completionSep 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00967902
Sponsor's protocol ID
VP-0427
Acronym
REMEDEE
Status last verified
Mar 2016
First submitted
26 Aug 2009
Last updated
29 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Haude M, Lee SW, Worthley SG, Silber S, Verheye S, Erbs S, Rosli MA, Botelho R, Meredith I, Sim KH, Stella PR, Tan HC, Whitbourn R, Thambar S, Abizaid A, Koh TH, Den Heijer P, Parise H, Cristea E, Maehara A, Mehran R. The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent. JACC Cardiovasc Interv. 2013 Apr;6(4):334-43. doi: 10.1016/j.jcin.2012.10.018. Epub 2013 Mar 20.

    PubMed 23523459

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing coronary stenting in people with Coronary Artery Lesions, run by OrbusNeich at 1 site in Australia.

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 13 inclusion and 31 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 Mar 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 Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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-stent late lumen loss of the Combo Stent compared to the TAXUS® Liberté® DES (time frame: 9 months post-procedure.). 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 NCT00967902, which also lists 1 linked publication.

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 Mar 2016.

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