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In-Stent RestenosisPhase 3NCT00231257

Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)

A Phase 3 study testing Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent and Brachytherapy in people with In-Stent Restenosis, run by Cordis US Corp. at 1 site in United States.

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

The main objective of this study is to demonstrate the superiority or non-inferiority of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with in-stent restenotic native coronary artery lesions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
In-Stent Restenosis
What is being tested?
Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent and Brachytherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
384 participants
Where
1 siteUnited States
Study dates
Feb 2003to Sep 2009
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

  • 1. The patient has an in-stent restenosis of > 50% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement ( 4 weeks). Lesions must meet ISR Classification I-III.
  • 2. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis. The diagnosis of angina pectoris is defined by Canadian Cardiovascular Society Classification (CCS I, II, III, or IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;
  • 3. The study target lesion must be located in an in-stent restenotic native coronary artery measuring > 2.75mm and 3.5mm in diameter and > 15mm and 40mm in length to allow treatment with a maximum of three 18mm stents. The target lesion must have undergone coronary interventional treatment > 4 weeks previously. Patients with one or more prior percutaneous coronary interventions at the target lesion are acceptable candidates.
  • 4. The vessel 1cm distal to the target lesion is > 2.5mm in diameter;
  • 5. Ejection Fraction must be > 40%;
  • 6. The study target lesion cannot be located in a vessel containing a second lesion requiring treatment at the time of the procedure.
  • 7. Male or non-pregnant female patients > 18 years of age inclusive. NOTE: Females of child-bearing potential must have a negative pregnancy test (urine or serum) prior to enrollment and must use birth control for 6 months.

Who cannot join

  • The study target lesion has definite or possible thrombus present by angiographic criteria.
  • The patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment.
  • Impaired renal function (Serum creatinine > 2.0mg/dl);
  • The patient has unstable angina classified as Braunwald III B or C, or is having peri infarction angina.
  • The left ventricular ejection fraction is < 40%.
  • The target vessel has previously sustained a perforation.
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  • Totally occluded vessel (TIMI 0 level);
  • Prior stent within 5mm of target lesion;
  • There is a total occlusion of the restenosed-stent (ISR Classification IV) prior to the interventional procedure.
  • Has an ostial target lesion;
  • Significant (> 50%) in-stent restenoses proximal or distal to the target lesion that might require revascularization or impede runoff;

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Multicenter, Randomized Study of the Sirolimus-Eluting Bx VELOCITY® BALLOON Expandable Stent vs. Intravascular Brachytherapy in the Treatment of Patients With In-Stent Restenotic Coronary Artery Lesions

The main objective of this study is to demonstrate the superiority or non-inferiority of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with in-stent restenotic native coronary artery lesions.

Being tested
Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent, Brachytherapy

What participants receive

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

  • Sirolimus-Eluting Bx Velocity® Balloon Expandable StentDevice

    Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent

  • BrachytherapyProcedure or surgery

    Brachytherapy

Study groups in NCT00231257
Study groupRoleWhat they receive
1ExperimentalCypher Bx Velocity
Receives: Device: Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
2Active comparatorBrachytherapy
Receives: Procedure: Brachytherapy

What is being measured

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

  1. Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure.

    Measured: 9 months post-procedure.

Secondary outcomes (9)

  1. Angiographic in-lesion and in-stent binary restenosis (³ 50% diameter stenosis) at 6 months post-procedure (by QCA).

    Measured: 6 months post-procedure

  2. Post-procedure and six-month in-stent and in-lesion percent diameter stenosis (%DS) and late loss at 6 months post-procedure (by QCA) - [analysis at 6 months chosen so that results from the GAMMA Trial can be used].

    Measured: 6 months post-procedure

  3. Post-procedure and six-month in-stent and in-lesion minimum lumen diameter (MLD) (by QCA).

    Measured: Post-procedure and at six-month

  4. Target lesion revascularization (TLR) at 6 and 9 months post-procedure.

    Measured: 6 and 9 months post-procedure

  5. Target vessel revascularization (TVR) at 6 and 9 months post-procedure.

    Measured: 6 and 9 months post-procedure

  6. Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-proce

    Measured: 30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-procedure

  7. Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of patients conducted at 5-7 investigational centers.

    Measured: post-procedure and six months

  8. Cost associated with the index hospitalization, length of stay, and repeat hospitalizations during the 12 mo post-procedure follow-up.

    Measured: 12 mo post-procedure

  9. Rate of late thrombosis

    Measured: Throughout study

Timeline

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

  1. First posted4 Oct 2005 (estimated)
  2. Study startFeb 2003
  3. Primary completionJan 2005
  4. Study completionSep 2009

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
None (open label)
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00231257
Sponsor's protocol ID
P02-6313
Status last verified
Nov 2009
First submitted
30 Sep 2005
Last updated
19 Nov 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Holmes DR Jr, Teirstein P, Satler L, Sketch M, O'Malley J, Popma JJ, Kuntz RE, Fitzgerald PJ, Wang H, Caramanica E, Cohen SA; SISR Investigators. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA. 2006 Mar 15;295(11):1264-73. doi: 10.1001/jama.295.11.1264. Epub 2006 Mar 12.

    PubMed 16531619

  • Holmes DR Jr, Teirstein PS, Satler L, Sketch MH Jr, Popma JJ, Mauri L, Wang HP, Schleckser PA, Cohen SA; SISR Investigators. 3-year follow-up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):439-48. doi: 10.1016/j.jcin.2008.05.010.

    PubMed 19463342

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent and Brachytherapy in people with In-Stent Restenosis, run by Cordis US Corp. at 1 site in United States.

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 7 inclusion and 11 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 19 Nov 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 United States. 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?

Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure. (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 NCT00231257, 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 19 Nov 2009.

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