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Coronary OcclusionsPhase 3NCT00378612

ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial

A Phase 3 study testing Cypher sirolimus eluting coronary stent in people with Coronary Occlusions, run by Sunil Rao at 16 sites in 2 countries.

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

ACROSS-Cypher® is a prospective, multi-center, open label, single arm study of the Cypher® sirolimus eluting coronary stent in native total coronary occlusion revascularization. The primary endpoint is binary angiographic restenosis at 6 months. The TOSCA-1 trial will be used as the historical control. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Occlusions
What is being tested?
Cypher sirolimus eluting coronary stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
16 sitesin 2 countries
Study dates
Jun 2005to Sep 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 age 18 years or older at time of consent
  • Patients with clinical symptoms suggesting ischemic heart disease or having evidence of myocardial ischemia and scheduled for clinically indicated percutaneous revascularization
  • Eligibility and consent to undergo PCI procedure
  • Patient is an acceptable candidate for percutaneous transluminal coronary angioplasty,stenting,and emergency coronary artery bypass grafting
  • Willing and able to sign informed consent form approved by local IRB/Ethics Committee and to follow protocol, including 6-month follow-up angiography
  • At least 1 target segment meeting definition of non-acute total coronary occlusion
Show all 12Show fewer
  • High-grade native coronary stenosis
  • Thrombolysis in Myocardial Infarction 0 or 1 antegrade flow
  • Target occlusion successfully crossed with commercially available coronary guidewire
  • Occluded segment suitable for placement of coronary stents
  • Treated segment can accommodate 3.0mm or greater diameter balloon
  • Segment not beyond severe tortuosity (45° or more) or excessively distal location

Who cannot join

  • Patients undergoing treatment of a non-target vessel that is also a total coronary occlusion
  • Patients with any history of allergy to iodinated contrast that cannot be effectively managed medically, or any known allergy to clopidogrel bisulfate (Plavix®), aspirin, heparin, ticlopidine, stainless steel, or sirolimus
  • Evidence of acute myocardial infarction within 72 hours of intended treatment (Q-wave or non-Q-wave myocardial infarction having creatine kinase enzymes 2X the upper limit of normal with presence of a creatine kinase myocardial-band isoenzyme above Institution's ULN, or troponin above the Institution's ULN)
  • Previous coronary interventional procedure of any kind within 3 months prior to the procedure in target vessel
  • Planned interventional treatment of either target or any non-target vessel within 30 days post-procedure with a bare metal or Cypher® sirolimus eluting coronary stent
  • Planned interventional treatment of either the target or any non-target vessel within 6 months post-procedure with a paclitaxel-eluting TAXUSTM stent
Show all 29Show fewer
  • Any contraindication to cardiac catheterization or to any standard concomitant therapies used during routine cardiac catheterization and PCI
  • Target lesion requires planned treatment with a device after successful crossing other than PTCA prior to stent
  • Patients with history of clinically significant abnormal laboratory findings including
  • Current (within previous two weeks) neutropenia (<1000 neutrophils/mm3)
  • Thrombocytopenia (<100,000 platelets/mm3)
  • AST, ALT, alkaline phosphatase, or bilirubin > 1.5XULN
  • Serum creatinine > 1.5 mg/dL
  • Patients with evidence of ongoing or active clinical instability including the following
  • Sustained systolic blood pressure < 100mmHg or cardiogenic shock
  • Acute pulmonary edema or severe congestive heart failure
  • Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
  • Suspected dissecting aortic aneurysm
  • Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
  • Target lesion involves a bifurcation including a diseased side branch 2.25mm or more in diameter requiring treatment
  • Prior coronary bypass surgery of target lesion with patent bypass graft (balloon angioplasty alone, without coronary stenting, is permitted)
  • History of stroke or transient ischemic attack within prior 6 months
  • Female patients of childbearing potential
  • Active peptic ulcer or upper gastrointestinal bleeding within prior 6 months
  • History of bleeding diathesis or coagulopathy or refusal of blood transfusions
  • Patients with any other pathology such as cancer, mental illness, which in the opinion of the investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study
  • Known previous medical condition yielding expected survival less than 1 year
  • Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
  • Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound, or other coronary artery imaging procedures

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

United States13 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Heart Hospital of Austin

    Austin, Texas, 78756

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • The Sanger Clinic PA

    Charlotte, North Carolina, 28203

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • North Ohio Heart Center

    Elyria, Ohio, 44035

  • Saint Lukes Hospital

    Kansas City, Missouri, 64111

  • Green Hospital of Scripps Health

    La Jolla, California, 92037

  • Scripps Memorial Hospital-La Jolla

    La Jolla, California, 92037

  • New York Presbyterian Medical

    New York, New York, 10032

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Canada3 sites

  • Saint Michaels Hospital

    Toronto, Ontario, M5B 1W8

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Vancouver Hospital and Health Science Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: Approaches to Chronic Occlusions With Sirolimus Stents-Cypher (ACROSS-Cypher) Total Occlusion Study of Coronary Arteries 4 Trial

ACROSS-Cypher® is a prospective, multi-center, open label, single arm study of the Cypher® sirolimus eluting coronary stent in native total coronary occlusion revascularization. The primary endpoint is binary angiographic restenosis at 6 months. The TOSCA-1 trial will be used as the historical control. The hypothesis is that compared with TOSCA-1 patients who were treated with the heparin-coated Palmaz Schatz stent, treatment with the Cypher® sirolimus eluting coronary stent will result in a >50% relative reduction in 6 month restenosis within the treated segment of the target vessel.

Read the detailed description

Despite remarkable advances in the procedural and clinical outcomes of percutaneous revascularization, chronically occluded coronary arteries remain a formidable challenge and unresolved dilemma in interventional cardiology. Although a TCO is identified in approximately one-third of diagnostic cardiac catheterizations, still an attempted revascularization accounts for less than 8% of all percutaneous coronary interventions (PCI). Such a disparity between their frequency and treatment not only underscores the technical and procedural frustrations associated with these complex lesions, but also the clinical uncertainties regarding clinical benefits with conventional TCO revascularization and the ongoing inadequacies of current PCI methods for sustaining restenosis-free patency following initial success.

Until recently, few clinical investigations have been performed to support clinical benefit of TCO revascularization. In addition to relief of symptomatic ischemia, theoretical advantages have included enhanced left ventricular function, reduced predisposition to arrhythmic events, and improved tolerance of future ischemic events. In the Survival and Ventricular Enlargement (SAVE) trial, persistent occlusion of the infarct-related artery was associated with a relative risk of 1.47 in adjusted 4-year mortality (P=0.04). Since then, a limited number of studies documenting long-term outcomes following intended TCO revascularization have been performed.

This investigational protocol is designed to evaluate the safety and efficacy of the Cypher® sirolimus eluting coronary stent (Cordis Corporation, Miami Lakes, FL) in patients undergoing elective revascularization of nonacute total coronary occlusions (TCO). Specifically, approximately 200 patients will undergo Cypher® sirolimus eluting coronary stent(s) implantation following successful crossing of native total occlusions with a coronary guidewire. The study will be conducted at approximately 17 sites in North America. Patients included in this trial will be scheduled for percutaneous revascularization of a non-acute de novo TCO in a native vessel visually estimated to accommodate a ≥3.0 mm diameter angioplasty balloon. Important exclusion criteria will include recent myocardial infarction (<72 hours) and any general contraindication to the procedure or scheduled clinical and angiographic follow-up. Patients may also undergo treatment of a non-target vessel lesion simultaneous with the index procedure within certain protocol-specified provisions. All patients will undergo planned angiographic follow-up 6 months following the index procedure to evaluate the primary endpoint of restenosis (>50% diameter stenosis) within the treated/working length segment compared with results obtained using the same methodology among patients undergoing TCO revascularization with the heparin-coated Palmaz-Schatz coronary stent (Cordis Corporation, Miami Lakes, FL) in the Total Occlusion Study of Canada-1 (TOSCA) (1). Important secondary endpoints include the occurrence of major adverse cardiac events (MACE) and target vessel failure (TVF) at 30 days, 6 months and 12 months post-procedure. In addition, angiographic outcomes of in-stent and segment restenosis within the stent and segment will be examined. Further, patients enrolled in the trial will have clinical follow-up annually to five years.

Being tested
Cypher sirolimus eluting coronary stent
Keywords
trials, stents, coronary occlusions
Medical subject headings
Coronary Occlusion

What participants receive

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

  • Cypher sirolimus eluting coronary stentDevice

    Cypher® sirolimus eluting coronary stent ranging in diameters 2.5 to 3.5 mm and available in length from 8 to 33 mm.

Study groups in NCT00378612
Study groupRoleWhat they receive
Cypher® sirolimus eluting coronary stentExperimentalAll pts were given the Cypher sirolimus eluting coronary stent in this open-label, single-arm, non-randomized trial
Receives: Device: Cypher sirolimus eluting coronary stent

What is being measured

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

  1. Angiographic binary restenosis (>=50% diameter stenosis) in TCO treated/working length compared with restenosis outcomes in the Total Occlusion Study of Canada (TOSCA)

    Measured: 6 months post-procedure

Secondary outcomes (13)

  1. Angiographic binary in-segment restenosis (>= 50% diameter stenosis) rate at 6 months post-procedure

    Measured: 6 months post-procedure

  2. Angiographic binary in-stent restenosis (>= 50% diameter stenosis) rate at 6 months post-procedure

    Measured: 6 months post-procedure

  3. In-segment late lumen loss at 6 months

    Measured: 6 months post-procedure

  4. In-stent late lumen loss at 6 months

    Measured: 6 months post-procedure

  5. Device Success

    Measured: 6 months post-procedure

  6. Lesion Success

    Measured: 6 months post-procedure

  7. Procedure Success

    Measured: 6 months post-procedure

  8. Major Adverse Cardiac Events (MACE) rate at 30 days, 6 months, and 12 months post-procedure

    Measured: 30 days, 6 months and 12 months post-procedure

  9. Target Site Revascularization (TSR) rate and clinically-driven TSR rate at 6 and 12 months post-procedure Target Vessel Revascularization (TVR) rate and clinically-driven TVR rate at 6 and 12 months post-procedure

    Measured: 6 and 12 months post-procedure

  10. Target Vessel Failure (TVF) rate at 6 and 12 months post-procedure

    Measured: 6 and 12 months post-procedure

  11. In-stent and in-segment minimum lumen diameter (MLD) at 6 months post-procedure

    Measured: 6 months post-procedure

  12. Failure of sustained patency at 6 months (≥70% stenosis with TIMI <3 flow at follow-up angiography)

    Measured: 6 months post-procedure

  13. Subacute thrombosis occurring within 30 days post-procedure

    Measured: 30 days post-procedure

Timeline

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

  1. First posted20 Sep 2006 (estimated)
  2. Study startJun 2005
  3. Primary completionApr 2007
  4. Study completionSep 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
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00378612
Sponsor's protocol ID
Pro00007965
Other IDs
1525004
Status last verified
Sep 2014
First submitted
19 Sep 2006
Last updated
12 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Buller CE, Dzavik V, Carere RG, Mancini GB, Barbeau G, Lazzam C, Anderson TJ, Knudtson ML, Marquis JF, Suzuki T, Cohen EA, Fox RS, Teo KK. Primary stenting versus balloon angioplasty in occluded coronary arteries: the Total Occlusion Study of Canada (TOSCA). Circulation. 1999 Jul 20;100(3):236-42. doi: 10.1161/01.cir.100.3.236.

    PubMed 10411846

  • Srinivas VS, Brooks MM, Detre KM, King SB 3rd, Jacobs AK, Johnston J, Williams DO. Contemporary percutaneous coronary intervention versus balloon angioplasty for multivessel coronary artery disease: a comparison of the National Heart, Lung and Blood Institute Dynamic Registry and the Bypass Angioplasty Revascularization Investigation (BARI) study. Circulation. 2002 Sep 24;106(13):1627-33. doi: 10.1161/01.cir.0000031570.27023.79.

    PubMed 12270854

  • Noguchi T, Miyazaki MD S, Morii I, Daikoku S, Goto Y, Nonogi H. Percutaneous transluminal coronary angioplasty of chronic total occlusions. Determinants of primary success and long-term clinical outcome. Catheter Cardiovasc Interv. 2000 Mar;49(3):258-64. doi: 10.1002/(sici)1522-726x(200003)49:33.0.co;2-l.

    PubMed 10700054

  • Ivanhoe RJ, Weintraub WS, Douglas JS Jr, Lembo NJ, Furman M, Gershony G, Cohen CL, King SB 3rd. Percutaneous transluminal coronary angioplasty of chronic total occlusions. Primary success, restenosis, and long-term clinical follow-up. Circulation. 1992 Jan;85(1):106-15. doi: 10.1161/01.cir.85.1.106.

    PubMed 1728439

  • Lamas GA, Flaker GC, Mitchell G, Smith SC Jr, Gersh BJ, Wun CC, Moye L, Rouleau JL, Rutherford JD, Pfeffer MA, et al. Effect of infarct artery patency on prognosis after acute myocardial infarction. The Survival and Ventricular Enlargement Investigators. Circulation. 1995 Sep 1;92(5):1101-9. doi: 10.1161/01.cir.92.5.1101.

    PubMed 7648653

  • Suero JA, Marso SP, Jones PG, Laster SB, Huber KC, Giorgi LV, Johnson WL, Rutherford BD. Procedural outcomes and long-term survival among patients undergoing percutaneous coronary intervention of a chronic total occlusion in native coronary arteries: a 20-year experience. J Am Coll Cardiol. 2001 Aug;38(2):409-14. doi: 10.1016/s0735-1097(01)01349-3.

    PubMed 11499731

  • Farr AD. Letter: Status of medical laboratory scientists. Br Med J. 1976 Jun 19;1(6024):1534. doi: 10.1136/bmj.1.6024.1534-d. No abstract available.

    PubMed 1276764

  • Maiello L, Colombo A, Gianrossi R, Mutinelli MR, Bouzon R, Thomas J, Finci L. Coronary angioplasty of chronic occlusions: factors predictive of procedural success. Am Heart J. 1992 Sep;124(3):581-4. doi: 10.1016/0002-8703(92)90262-t.

    PubMed 1514482

  • Sirnes PA, Golf S, Myreng Y, Molstad P, Emanuelsson H, Albertsson P, Brekke M, Mangschau A, Endresen K, Kjekshus J. Stenting in Chronic Coronary Occlusion (SICCO): a randomized, controlled trial of adding stent implantation after successful angioplasty. J Am Coll Cardiol. 1996 Nov 15;28(6):1444-51. doi: 10.1016/s0735-1097(96)00349-x.

    PubMed 8917256

  • Hoher M, Wohrle J, Grebe OC, Kochs M, Osterhues HH, Hombach V, Buchwald AB. A randomized trial of elective stenting after balloon recanalization of chronic total occlusions. J Am Coll Cardiol. 1999 Sep;34(3):722-9. doi: 10.1016/s0735-1097(99)00254-5.

    PubMed 10483953

  • Rubartelli P, Niccoli L, Verna E, Giachero C, Zimarino M, Fontanelli A, Vassanelli C, Campolo L, Martuscelli E, Tommasini G. Stent implantation versus balloon angioplasty in chronic coronary occlusions: results from the GISSOC trial. Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche. J Am Coll Cardiol. 1998 Jul;32(1):90-6. doi: 10.1016/s0735-1097(98)00193-4.

    PubMed 9669254

  • Mori M, Kurogane H, Hayashi T, Yasaka Y, Ohta S, Kajiya T, Takarada A, Yoshida A, Matsuda Y, Nakagawa K, Murata T, Yoshida Y, Yokoyama M. Comparison of results of intracoronary implantation of the Plamaz-Schatz stent with conventional balloon angioplasty in chronic total coronary arterial occlusion. Am J Cardiol. 1996 Nov 1;78(9):985-9. doi: 10.1016/s0002-9149(96)00521-8.

    PubMed 8916475

  • Lotan C, Rozenman Y, Hendler A, Turgeman Y, Ayzenberg O, Beyar R, Krakover R, Rosenfeld T, Gotsman MS. Stents in total occlusion for restenosis prevention. The multicentre randomized STOP study. The Israeli Working Group for Interventional Cardiology. Eur Heart J. 2000 Dec;21(23):1960-6. doi: 10.1053/euhj.2000.2295.

    PubMed 11071802

  • Sedel'nikov GN. [Friendship and cooperation]. Voen Med Zh. 1976 Mar;(3):78-81. No abstract available. Russian.

    PubMed 1274228

  • Sirnes PA, Golf S, Myreng Y, Molstad P, Albertsson P, Mangschau A, Endresen K, Kjekshus J. Sustained benefit of stenting chronic coronary occlusion: long-term clinical follow-up of the Stenting in Chronic Coronary Occlusion (SICCO) study. J Am Coll Cardiol. 1998 Aug;32(2):305-10. doi: 10.1016/s0735-1097(98)00247-2.

    PubMed 9708454

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cypher sirolimus eluting coronary stent in people with Coronary Occlusions, run by Sunil Rao at 16 sites in 2 countries.

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 12 inclusion and 29 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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Canada. 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?

Angiographic binary restenosis (>=50% diameter stenosis) in TCO treated/working length compared with restenosis outcomes in the Total Occlusion Study of Canada (TOSCA) (time frame: 6 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 NCT00378612, which also lists 50 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 12 Sep 2014.

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