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Coronary Artery DiseasePhase 3RESERVOIRNCT01710748

Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients

A Phase 3 study testing Polymer-Based Everolimus-Eluting Stent and Polymer-Free Amphilimus-Eluting Stent in people with Coronary Artery Disease and Diabetes Mellitus, run by Spanish Society of Cardiology at 4 sites in Spain.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is a prospective, randomized controlled, single blind, two-arm, multicenter clinical evaluation. Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2) Polymer-Based Everolimus-Eluting… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Diabetes Mellitus
What is being tested?
Polymer-Based Everolimus-Eluting Stent and Polymer-Free Amphilimus-Eluting Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
4 sitesSpain
Study dates
Oct 2012to Oct 2014
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Clinical Inclusion Criteria:

  • Subject is eligible for PCI.
  • Subject has symptomatic coronary artery disease (stable/unstable angina or Non-ST elevation myocardial infarction).
  • Subject has known DM.

Angiographic Inclusion Criteria:

  • Presence of 1 or 2 de novo native coronary artery lesions (maximum 1 lesion per epicardial coronary artery), with a visual estimation stenosis ≥ 50%.
  • Target lesion length 12-25mm, reference diameter 2.5-3.5mm.

Clinical Exclusion Criteria:

  • ST-segment elevation myocardial infarction <48h
  • Presence of cardiogenic shock pre-procedure
  • Contra-indications to dual antiplatelet therapy for 12 months
  • Left Ventricular Ejection Fraction ≤30%
  • GFR<30 ml/min/m2
  • Target vessel has been treated previously
  • Platelet count <75000/mm3 or >700000/mm3
  • Immunosuppressive therapy
  • Has received or waiting list for any transplant
  • Life-threatening disease with a life expectancy of < 12 months
  • Pregnant or breast feeding patient
  • Inability to provide informed consent

Angiographic Exclusion Criteria:

  • TIMI flow ≤ 1 prior to guide wire crossing
  • There is an additional lesion within the target vessel planned to be treated within the next 12 months
  • Target vessel is a saphenous vein graft
  • Target vessel is the left main, ostial LAD and/or ostial LCX.
  • Prior PCI of the target lesion (restenosis)
  • Lesion cannot be covered by a single stent (unplanned bailout stenting is allowed)
  • Involved side branch ≥2.5mm by visual estimation
  • Rotablator, ELCA or brachytherapy
  • Severe calcification of target lesion

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Hospital Clínic i Provincial

    Barcelona, Barcelona

  • Hospital Universitari de Bellvitge

    Barcelona, Barcelona

  • Hospital Clínico San Carlos

    Madrid, Madrid

  • Hospital Virgen de la Arrixaca

    Murcia, Murcia

Other trials in Spain

About this study

Official title: Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial

This study is a prospective, randomized controlled, single blind, two-arm, multicenter clinical evaluation.

Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2) Polymer-Based Everolimus-Eluting Stent.

The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as the primary imaging modality.

Read the detailed description

In patients with diabetes mellitus (DM), drug eluting stents (DES) have been shown to be associated with greater neointimal suppression than bare-metal stents. However, there is an ongoing debate on the optimal drug-eluting stent in diabetic patients.

This study is a prospective, randomized controlled, single blind, two-arm, multicenter clinical evaluation.

Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2) Polymer-Based Everolimus-Eluting Stent.

The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as the primary imaging modality.

Being tested
Polymer-Based Everolimus-Eluting Stent, Polymer-Free Amphilimus-Eluting Stent
Keywords
Percutaneous coronary intervention, Drug eluting stent, Neointimal hyperplasia, Diabetes Mellitus
Medical subject headings
Coronary Artery Disease, Diabetes Mellitus

What participants receive

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

  • Polymer-Based Everolimus-Eluting StentDevice

    Also called Xience Coronary Stent System

    Polymer-Based Everolimus-Eluting Stent

  • Polymer-Free Amphilimus-Eluting StentDevice

    Also called Cre8 Coronary Stent System

    Reservoir-Based Polymer-Free Amphilimus-Eluting Stent

Study groups in NCT01710748
Study groupRoleWhat they receive
Polymer-Based Everolimus-Eluting StentActive comparatorPolymer-Based Everolimus-Eluting Stent
Receives: Device: Polymer-Based Everolimus-Eluting Stent
Polymer-Free Amphilimus-Eluting StentExperimentalReservoir-Based Polymer-Free Amphilimus-Eluting Stent
Receives: Device: Polymer-Free Amphilimus-Eluting Stent

What is being measured

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

  1. Neointimal hyperplasia volume obstruction

    The primary endpoint is assessed by Optical Coherence Tomography. It is defined as neointimal hyperplasia volume (mm3) divided by the stent volume multiplied by 100.

    Measured: 9 months

Secondary outcomes (6)

  1. Percentage of uncovered struts

    This endpoint is assessed by Optical Coherence Tomography. Struts are classified as uncovered if any part of the strut is visibly exposed to the lumen, or covered if a layer of tissue is visible over all the reflecting surfaces.

    Measured: 9 months

  2. Percentage of malapposed struts

    This endpoint is assessed by Optical Coherence Tomography. Apposition is assessed strut by strut by measuring the distance between the strut marker and the lumen contour. Struts with distance to lumen contour larger than the sum of strut + polymer thickness are considered malapposed. This results in incomplete strut apposition thresholds of 89 µm for the Xience Prime and 80 µm for the Cre8 stent. Struts located at the ostium of side branches, with no vessel wall behind, are excluded from the analysis of apposition.

    Measured: 9 months

  3. Maximum percentage of NIH cross-sectional obstruction

    This endpoint is assessed by Optical Coherence Tomography. Percentage of NIH cross-sectional obstruction is defined as the NIH area (mm2) divided by the stent area multiplied by 100.

    Measured: 9 months

  4. Cardiac death

    Death related to cardiac causes; if the cause of death cannot be determined, it will be also categorized as cardiac.

    Measured: 12 months

  5. Probable or definite stent thrombosis

    Stent thrombosis is considered according to the Academic Research Consortium definitions

    Measured: 12 months

  6. Target vessel failure

    Target vessel failure is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated revascularization of the target vessel.

    Measured: 12 months

Timeline

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

  1. First posted19 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJul 2014 (estimated)
  4. Study completionOct 2014 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01710748
Sponsor's protocol ID
SEC-RES-2012-01
Acronym
RESERVOIR
Status last verified
Nov 2013
First submitted
17 Oct 2012
Last updated
6 Nov 2013
Results posted
No
Data monitoring committee
No

Publications

  • Romaguera R, Gomez-Hospital JA, Gomez-Lara J, Brugaletta S, Pinar E, Jimenez-Quevedo P, Gracida M, Roura G, Ferreiro JL, Teruel L, Montanya E, Fernandez-Ortiz A, Alfonso F, Valgimigli M, Sabate M, Cequier A. A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus: The RESERVOIR Clinical Trial. JACC Cardiovasc Interv. 2016 Jan 11;9(1):42-50. doi: 10.1016/j.jcin.2015.09.020.

    PubMed 26762910

  • Romaguera R, Brugaletta S, Gomez-Lara J, Pinar E, Jimenez-Quevedo P, Gracida M, Roura G, Ferreiro JL, Teruel L, Gomez-Hospital JA, Montanya E, Alfonso F, Valgimigli M, Sabate M, Cequier A. Rationale and study design of the RESERVOIR trial: a randomized trial comparing reservoir-based polymer-free amphilimus-eluting stents versus everolimus-eluting stents with durable polymer in patients with diabetes mellitus. Catheter Cardiovasc Interv. 2015 Mar;85(4):E116-22. doi: 10.1002/ccd.25728. Epub 2014 Nov 27.

    PubMed 25380051

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Polymer-Based Everolimus-Eluting Stent and Polymer-Free Amphilimus-Eluting Stent in people with Coronary Artery Disease and Diabetes Mellitus, run by Spanish Society of Cardiology at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

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?

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?

Neointimal hyperplasia volume obstruction (time frame: 9 months). 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 NCT01710748, 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 6 Nov 2013.

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