AzTrials
AzTrials

Coronary Artery DiseasePhase 3NCT00130546

Intra-Individual Comparison of Sirolimus and Paclitaxel Coated Stent (FRE-RACE Study)

A Phase 3 study testing Paclitaxel-eluting TAXUS(TM) and Sirolimus eluting Cypher Select(TM) in people with Coronary Artery Disease, run by University Hospital Freiburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting with two or more coronary artery… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Paclitaxel-eluting TAXUS(TM) and Sirolimus eluting Cypher Select(TM)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteGermany
Study dates
Nov 2004to Jul 2008
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient must be >=18 and <=85 years of age
  • Female of childbearing potential must have a negative pregnancy test at the time of enrolment and utilize reliable birth control for the duration of their participation in the trial
  • 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) and documented ischemia OR patients with documented silent ischemia
  • Two or more de novo lesions < 30 mm in length (visual estimate)
  • Target vessel at lesion site is ≥ 2.25 mm and ≤ 3.0 mm in diameter (visual estimate)
  • Target lesion is located in a native coronary artery which can be covered by one stent (single lesion)
Show all 11Show fewer
  • Acceptable candidate for coronary artery bypass surgery (CABG)
  • Target lesion stenosis is > 50% and < 100% (thrombolysis in myocardial infarction [TIMI] 1) (visual estimate)
  • Target lesions do not differ in length for more than 6 mm
  • Patient is willing to comply with the specified follow-up evaluation
  • Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee

Who cannot join

  • Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal
  • Unprotected left main coronary disease with >= 50% stenosis
  • Impaired runoff in the treatment vessel with diffuse distal disease
  • Ostial target lesion
  • Angiographic evidence of thrombus within target lesion
  • Calcified lesions which cannot be successfully predilated
Show all 22Show fewer
  • Ejection fraction <= 30%
  • Totally occluded vessel (TIMI 0 level)
  • Impaired renal function (creatinine > 3.0 mg/dl)
  • Pretreatment with devices other than balloon angioplasty
  • Target lesion has excessive tortuosity unsuitable for stent delivery and deployment
  • Target lesion involves bifurcation including a side branch >= 2.5 mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented
  • Prior stent within 5 mm of target lesion this includes in-stent restenosis
  • Significant (> 50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff
  • Intervention of another lesion has occurred within one month before or is planned or highly probable to be performed within the next 30 days after this index procedure
  • Recipient of heart transplant
  • Patient with a life expectancy less than 12 months
  • Known allergies to aspirin, clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®), heparin stainless steel, contrast agent, Paclitaxel or Sirolimus
  • Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study
  • Target lesion located in an arterial or venous by-pass graft
  • Currently participating in an investigational drug or another device study
  • Unstable angina pectoris Braunwald Classification A I-II-III or is having a peri-infarction

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Albert-Ludwig University Clinic

    Freiburg im Breisgau, Baden-Wurttemberg, 79116

Other trials in Germany

About this study

Official title: A Prospective, Randomized Intra-Individual Study With the Sirolimus Coated Cypher Select(TM) and the Paclitaxel(TM) Coated Express Balloon Expandable Stents for the Treatment of Patients With Two de Novo Native Coronary Artery Lesions.

The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting with two or more coronary artery stenoses (prospective, randomized, intra-individual comparison).

Read the detailed description

This is a prospective, 2 arm, randomized, multicenter Phase III study (6 centers).

A total of 110 patients with at least two de novo native coronary artery lesions (lesion A, lesion B) ≤ 30 mm in length and ≥ 2.25 mm to < 3.0 mm in diameter by visual estimate will be enrolled. Patients will be randomized for implantation of the sirolimus eluting Cypher Select(TM) Balloon-Expandable Stent or to the TAXUS(TM) Paclitaxel-eluting stent for lesion A and B.

Being tested
Paclitaxel-eluting TAXUS(TM), Sirolimus eluting Cypher Select(TM)
Keywords
coronary artery disease, coronary intervention, drug eluting stent implantation, Cypher - Stent, Sirolimus, Taxus - Stent, Paclitaxel
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.

  • Paclitaxel-eluting TAXUS(TM)Device

    TAXUS(TM) Paclitaxel-eluting stent

  • Sirolimus eluting Cypher Select(TM)Device

    Sirolimus eluting Cypher Select(TM) stent

Study groups in NCT00130546
Study groupRoleWhat they receive
1Active comparatorCypher Stent
Receives: Device: Sirolimus eluting Cypher Select(TM)
2Active comparatorTaxus Stent
Receives: Device: Paclitaxel-eluting TAXUS(TM)

What is being measured

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

  1. The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography

    Measured: 8 months

Secondary outcomes (2)

  1. Target lesion and vessel revascularization (TLR, TVR)

    Measured: 12 months

  2. Major adverse cardiac events (MACE) at 30 days, 8 and 12 months

    Measured: 30 days, 8 and 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 posted15 Aug 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionJul 2008
  4. Study completionJul 2008

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
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00130546
Sponsor's protocol ID
FreRace-Study 186/02
Status last verified
May 2009
First submitted
11 Aug 2005
Last updated
15 May 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel-eluting TAXUS(TM) and Sirolimus eluting Cypher Select(TM) in people with Coronary Artery Disease, run by University Hospital Freiburg at 1 site in Germany.

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 11 inclusion and 22 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 15 May 2009. 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 Germany. 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?

The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography (time frame: 8 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 NCT00130546.

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 15 May 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in