Coronary Artery DiseasePhase 4CRISTALNCT00323895

The Intra-Drug Eluting Stent (DES) Restenosis Study

A Phase 4 study testing drug-eluting stent and balloon angioplasty and drug-eluting stent in people with Coronary Artery Disease, run by Cordis US Corp. at 2 sites 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

A Prospective, Randomized, Multi-Center Comparison of the Cypher Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: drug-eluting stent and balloon angioplasty and drug-eluting stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: 2 sitesFrance
Study dates: Mar 2006to Jan 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
Patient has an intra-DES (TAXUS™ OR CYPHER™) or intra-BMS restenosis of >= 50% and <100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery;
Study target lesion must be located in a restenotic native coronary artery >=2.25mm and <=3.5mm in lumen diameter and <=30mm in length by visual estimate and within a region up to 5mm to the proximal/distal stent edge;
Study target lesion must have undergone coronary interventional treatment >= 4 weeks previously. Patients with one ore more prior PTCA procedures at the target lesion are acceptable candidates.
Study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion;
Patient is candidate for a current percutaneous revascularisation technique;
Patient is willing to comply with the specified follow-up evaluations (including angiographic follow-up);
Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee;

Who cannot join

Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 72 hours and the CK enzymes remain above normal at the time of treatment;
Has unstable angina classified as Braunwald A I-II-III;
Unprotected left main coronary disease with ³50% stenosis;
Significant (>50%) stenoses of additional lesions proximal or distal to the target lesion(s) that might require revascularization or impede runoff;
Target lesion is in an internal mammary artery, saphenous vein bypass graft or is located in the left main or is ostial;
Stent implantation(s) is a non-elective, emergency procedure;

Show all 9Show fewer

Stent at the target restenosed lesion is neither TAXUS™ , CYPHER™ DES nor a BMS;
Documented left ventricular ejection fraction <=25%;
Totally occluded vessel (TIMI 0 level).

Trial locations and contacts

2 sites in 1 country.

France2 sites

Centre Cardiologique du Nord
Saint-Denis
Unite de Cardiologie Interventionelle
Toulouse, 4131076

Other trials in France

About this study

Official title: A Prospective, Randomized, Multi-Center Comparison of the CYPHER Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients With Intra-Des Restenosis

A Prospective, Randomized, Multi-Center Comparison of the Cypher Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis.

Read the detailed description

This is a prospective, randomized study to be conducted at up to 33 sites in France with 3 groups of patients (1 group with intra-Taxus™ restenosis, 1 group with intra-Cypher™ restenosis and 1 control group with intra-BMS restenosis). All patients will have a repeat angiography at 9 to 12 months post-procedure and will be followed up to 12 months post-procedure.

Conditions: Coronary Artery Disease
Being tested: drug-eluting stent and balloon angioplasty, drug-eluting stent
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.

drug-eluting stent and balloon angioplastyDevice
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
drug-eluting stent and balloon angioplastyDevice
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
drug-eluting stentDevice
CYPHER Select ™ Sirolimus-eluting Stent

Study groups in NCT00323895
Study group	Role	What they receive
1	Experimental	group with intra-Cypher™ restenosis Receives: Device: drug-eluting stent and balloon angioplasty
2	Active comparator	group with intra-Taxus™ restenosis Receives: Device: drug-eluting stent and balloon angioplasty
3	Active comparator	group with intra-BMS restenosis Receives: Device: drug-eluting stent

What is being measured

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

In stent late loss.
Measured: between 9 - 12 months

Secondary outcomes (7)

In-stent, in-segment, and in-lesion binary restenosis rate by QCA.
Measured: between 9 - 12 months
In-lesion late loss as assessed by QCA.
Measured: between 9 - 12 months
In-stent and in-lesion MLD, and percent diameter stenosis (%DS) as assessed by QCA.
Measured: between 9 - 12 months
Target lesion revascularization (TLR).
Measured: 30 days, 6 and 12 months
Target vessel revascularization (TVR).
Measured: 30 days, 6 and 12 months
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization.
Measured: 30 days, 6 and 12 months
Composite of Major Adverse Cardiac Events (MACE) defined as cardiac death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization.
Measured: 30 days, 6 months and 12 months

Timeline

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

Mar 2006Jan 2010

First posted10 May 2006 (estimated)
Study startMar 2006
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 320 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00323895
Sponsor's protocol ID: EC05-02
Acronym: CRISTAL
Status last verified: Jul 2010
First submitted: 9 May 2006
Last updated: 29 Jul 2010
Results posted: No
Data monitoring committee: Yes

Publications

Chevalier B, Moulichon R, Teiger E, Brunel P, Metzger JP, Pansieri M, Carrie D, Stoll HP, Wittebols K, Spaulding C, Fajadet J; Cristal Investigators. One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents. J Interv Cardiol. 2012 Dec;25(6):586-95. doi: 10.1111/j.1540-8183.2012.00769.x. Epub 2012 Sep 20.
PubMed 22994863

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Multi-Center Comparison of the CYPHER Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients With Intra-Des Restenosis
ClinicalTrials.gov ID: NCT00323895
Acronym / sponsor ID: CRISTAL / EC05-02
Conditions: Coronary Artery Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (estimated)
Lead sponsor: Cordis US Corp.Industry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 10 May 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Prospective, Randomized, Multi-Center Comparison of the Cypher Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Device: drug-eluting stent and balloon angioplastygroup with intra-Cypher™ restenosis
2	Active comparator	Device: drug-eluting stent and balloon angioplastygroup with intra-Taxus™ restenosis
3	Active comparator	Device: drug-eluting stentgroup with intra-BMS restenosis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
Patient has an intra-DES (TAXUS™ OR CYPHER™) or intra-BMS restenosis of >= 50% and <100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery;
Study target lesion must be located in a restenotic native coronary artery >=2.25mm and <=3.5mm in lumen diameter and <=30mm in length by visual estimate and within a region up to 5mm to the proximal/distal stent edge;
Study target lesion must have undergone coronary interventional treatment >= 4 weeks previously. Patients with one ore more prior PTCA procedures at the target lesion are acceptable candidates.
Study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion;

Key exclusion criteria (9 listed)

Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 72 hours and the CK enzymes remain above normal at the time of treatment;
Has unstable angina classified as Braunwald A I-II-III;
Unprotected left main coronary disease with ³50% stenosis;
Significant (>50%) stenoses of additional lesions proximal or distal to the target lesion(s) that might require revascularization or impede runoff;
Target lesion is in an internal mammary artery, saphenous vein bypass graft or is located in the left main or is ostial;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
drug-eluting stent and balloon angioplastyCYPHER Select ™ Sirolimus-eluting Stent and any balloon brand	Device	1
drug-eluting stent and balloon angioplastyCYPHER Select ™ Sirolimus-eluting Stent and any balloon brand	Device	2
drug-eluting stentCYPHER Select ™ Sirolimus-eluting Stent	Device	3

Primary outcome

In stent late loss.
Time frame: between 9 - 12 months

7 secondary outcomes

In-stent, in-segment, and in-lesion binary restenosis rate by QCA.
Time frame: between 9 - 12 months
In-lesion late loss as assessed by QCA.
Time frame: between 9 - 12 months
In-stent and in-lesion MLD, and percent diameter stenosis (%DS) as assessed by QCA.
Time frame: between 9 - 12 months
Target lesion revascularization (TLR).
Time frame: 30 days, 6 and 12 months
Target vessel revascularization (TVR).
Time frame: 30 days, 6 and 12 months
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization.
Time frame: 30 days, 6 and 12 months
Composite of Major Adverse Cardiac Events (MACE) defined as cardiac death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization.
Time frame: 30 days, 6 months and 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2010.
Derived from this study: PubMed 22994863Chevalier B, Moulichon R, Teiger E, Brunel P, Metzger JP, Pansieri M, Carrie D, Stoll HP, Wittebols K, Spaulding C, Fajadet J; Cristal Investigators. One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents. J Interv Cardiol. 2012 Dec;25(6):586-95. doi: 10.1111/j.1540-8183.2012.00769.x. Epub 2012 Sep 20.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bernard Chevalier, MD principal investigator

Centre Cardiologique du Nord, Saint Denis, France

Jean Fajadet, MD, PhD principal investigator

Unité de Cardiologie Interventionnelle, Toulouse Cedex 3, France

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing drug-eluting stent and balloon angioplasty and drug-eluting stent in people with Coronary Artery Disease, run by Cordis US Corp. at 2 sites 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 8 inclusion and 9 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 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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 stent late loss. (time frame: between 9 - 12 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 NCT00323895, 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 Jul 2010.