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Coronary RestenosisPhase 3XERESNCT00882219

Clinical Evaluation of Patients With Everolimus-eluting Stent Xience V® Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period

A Phase 3 study testing Xience V® in people with Coronary Restenosis, run by Abbott Medical Devices at 1 site in France.

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

Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Restenosis
What is being tested?
Xience V®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteFrance
Study dates
Mar 2009to Jul 2012
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

Who may be able to join

  • Patients 18 years of age or older
  • Patients affiliated to a social security or equivalent regimen
  • Patients agreeing to participate in the study (Patient with signed informed consent )
  • Patients with evidence of myocardial ischemia (stable or unstable angina, silent ischemia, positive functional exploration or a reversible modification in the ECG consistent with ischemia).
  • Patient acceptable candidate for CABG surgery
  • Patient agreeing to undergo all protocol scheduled follow-up examinations.
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  • Patients who tolerate the association Aspirin (dosed 75 to 160 mg/day) and Clopidogrel at 75 mg/day for at least 6 months
  • Angiographic inclusion criteria:
  • Patient with de novo and sole in-stent restenosis (focal, diffuse or proliferative) in a non-coated metallic stent with or without any other coronary lesions.
  • Patient with target reference vessel diameter between 2.5 and 4 mm by visual estimate
  • Patient with a target lesion ≤ 22mm by visual estimate
  • Patient with a target lesion in an artery with a visual estimate of the restenosis between 50 and 99% and a TIMI flow grade > 1
  • Patient with multiple lesions, the other lesions have been treated with success

Who cannot join

  • Patient in emergency
  • Patient pregnant
  • Patient nursing
  • Patient unable to give informed consent personally.
  • Patient with myocardial infarction within the previous 72 hours.
  • Patient with limited life expectancy (lesser than 1 year post-inclusion)
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  • Patient with unstable arrhythmia
  • Patient with left ventricular ejection fraction (LVEF) lesser than 30%
  • Patient receiver of a cardiac or any other organ transplantation or candidate to an organ transplant
  • Patient who receive or scheduled to receive chemo- or radio- therapy within the 30 days prior to any protocol-related procedure.
  • Patient treated with immunosuppressives or for known immunodepressive or auto-immune pathologies
  • Patient receiving chronically anticoagulant therapy with an INR greater than 2.5
  • Patient with known hypersensitivity or contraindications to anti-platelet drugs, everolimus, heparin, chromium cobalt alloys, nickel, tungsten, acrylic- or fluoro- polymers or sensitivity to angiographic contrast agents.
  • Patient with planned elective surgery requiring the interruption or discontinuation of anti-platelet therapy.
  • Patient with platelet count <100 000/ mm3 or >700 000mm3 ; WBC counts <3 000/mm3 or known or suspected liver disease
  • Patient with severe renal insufficiency (creatinine clearance rate < 30 ml/min), or under dialysis
  • Patient with an history of coagulopathy refusing blood transfusion
  • Patient who had a stroke/cerebrovascular accident or transient cerebrovascular ischemia in the preceding 6 months
  • Patient with urinary or gastro-intestinal bleed in the preceding 6 months
  • Patient with other known serious medical illness or known history of substance abuse (alcohol, drugs) that might result in non-compliance to the investigational plan, or interfere with the results or diminish the life expectancy to less than a year.
  • Patient enrolled in an interventional study with another medical device or drug Angiographic exclusion criteria
  • Patient with in-stent restenosis located on the left main on the coronary by-pass
  • Patient with a lesion of the in-stent restenosis located in a bifurcation including a lateral branch of diameter > 1.5mm
  • Patient with the target vessel totally occluded
  • Patient with a lesion of the restenosis previously treated with another device (with the exception of balloon-tipped catheter) such as a cutting balloon, an atherectomy, laser, brachytherapy or any another medicated stent.
  • Patient with thrombus in the target vessel
  • Patient with aorto-ostiale lesions
  • Patient with previous failures of multiple lesions treated by angioplasty.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital de Rangueil - Chu

    Toulouse, 31403

Other trials in France

About this study

Official title: XERES Trial: Clinical Evaluation of Patients With Everolimus-eluting Stent " Xience V® " Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period

Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.

Being tested
Xience V®
Keywords
Drug eluting stent, Stents, Angioplasty, Chronic coronary occlusion, Stent thrombosis, Vascular disease, Myocardial ischemia, Coronary artery stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Medical subject headings
Coronary Restenosis, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Artery Disease

What participants receive

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

  • Xience V®Device

    Placement of a Xience V® stent within a restenosed bare metal stent.

Study groups in NCT00882219
Study groupRoleWhat they receive
Xience V®ExperimentalNot described
Receives: Device: Xience V®

What is being measured

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

  1. Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V®

    Measured: 9 months

Secondary outcomes (10)

  1. Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent

    Measured: 9 months

  2. Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent

    Measured: 9 months

  3. Evaluation by QCA of the in-stent binary restenosis rate

    Measured: 9 months

  4. Evaluation of the in-segment binary restenosis rate

    Measured: 9 months

  5. Evaluation by QCA of in-segment late loss

    Measured: 9 months

  6. Evaluation by IVUS of the in-segment % volume obstruction after the implantation of the XIENCE V® stent

    Measured: 9 months

  7. Evaluation by IVUS of the rate of late incomplete apposition

    Measured: 9 months

  8. Document the number of confirmed stent thrombosis

    Measured: 1, 8, 9, 12 and 24 months

  9. -Document the number of confirmed revascularizations (TLR, TVR)

    Measured: 1, 8, 9, 12 and 24 months

  10. Document the rate of MACE

    Measured: 1, 8, 9, 12 and 24 months

Timeline

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

  1. First posted16 Apr 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2011
  4. Study completionJul 2012

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00882219
Sponsor's protocol ID
330704
Acronym
XERES
Status last verified
Sep 2012
First submitted
14 Apr 2009
Last updated
6 Sep 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xience V® in people with Coronary Restenosis, run by Abbott Medical Devices at 1 site in France.

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 28 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 6 Sep 2012. 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 France. 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?

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?

Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V® (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 NCT00882219.

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 Sep 2012.

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