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Coronary Artery StenosisPhase 1/2NCT00934752

De Novo Pilot Study, Lutonix Catheter in Conjunction With Bare Metal Stenting for Treatment of Coronary De Novo Lesions

A Phase 1/2 study testing Lutonix Paclitaxel-Coated Balloon in people with Coronary Artery Stenosis, run by C. R. Bard at 3 sites in Netherlands.

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 study will enroll patients with angiographically significant coronary de novo lesions. Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after bare-metal stenting (BMS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Stenosis
What is being tested?
Lutonix Paclitaxel-Coated Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesNetherlands
Study dates
Jul 2009to Jan 2012
Phase
Phase 1/2
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

  • Male or non-pregnant/non-breast feeding Female ≥ 18 years of age. Women of childbearing potential must have a negative pregnancy test (within 7 days of the procedure);
  • Documented stable angina pectoris Canadian Cardiovascular Society Classification (CCSC) 1-4, unstable angina pectoris with documented ischemia (Braunwald I-II) or documented silent ischemia;
  • Left ventricular ejection fraction (LVEF) ≥ 25%;
  • Patient is an acceptable candidate for PTCA, stenting, and emergent coronary artery bypass grafting (CABG);
  • Patient is willing to provide informed consent and comply with follow-up visits and testing schedule;
  • Target lesion is a de novo lesion in a native coronary artery vessel;
Show all 11Show fewer
  • Initial stenosis is ≥ 50% and < 100% by visual estimate or quantitative coronary angiography (QCA);
  • Reference Vessel Diameter (RVD) is ≥ 2.5 and ≤ 3.25 prior to predilation;
  • Target lesion is ≤18mm in length and can be treated in its entirety by no more than 1 single Lutonix Catheter balloon and 1 single BMS;
  • Guidewire is able to cross lesion and be placed in distal vessel prior to enrollment;
  • Enrollment permitted after successful treatment of 1 non-study lesion in a single other non-study vessel (not in the same vascular territory as the study lesion). Successful treatment is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of dissection.

Who cannot join

  • History of stroke within past 6 months;
  • History of myocardial infarction (MI) or thrombolysis within 72 hours of randomization;
  • Prior vascular brachytherapy;
  • Uncontrollable allergies to procedure medications, materials or contrast;
  • Angiographic evidence of thrombus or dissection within the target vessel;
  • Intervention of another coronary lesion ≤ 60 days before index procedure day or planned following index procedure;
Show all 18Show fewer
  • Target lesion is planned to be treated with something other than PTCA and stent (i.e., cutting-balloon, atherectomy, vascular brachytherapy (VBT), etc.);
  • Target lesion is in the Left Main and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥ 2.5mm;
  • Known sensitivity or has received paclitaxel or other antimitogenic agent within 12 months prior to target vessel treatment;
  • Patient has any previous intervention (PTCA, stent, etc.) of the target coronary vessel;
  • Any medical condition, in the investigators opinion, that should preclude the patient from the study or patient has a life expectancy less than 24 months;
  • Known creatine kinase-MB (CKMB) > 2x upper limit of normal (ULN) or positive Troponin;
  • Creatinine > 2.0 mg/dl;
  • Leukocyte < 3500/mL;
  • Platelet < 100,000 mL or > 750,000 mL;
  • Currently taking or must resume warfarin;
  • Patient is contraindicated for antiplatelet therapy or it will need to be withdrawn for a planned procedure;
  • The subject is currently participating in another investigational drug or device study.

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Academic Medical Center

    Amsterdam

  • Catherina Zeikenhuis

    Eindhoven

  • Thorax Center

    Rotterdam

Other trials in Netherlands

About this study

Official title: An Exploratory Study Investigating the Use of the Lutonix Paclitaxel-Coated Balloon in Conjunction With Bare Metal Stenting in Patients With De Novo Coronary Lesions.

The study will enroll patients with angiographically significant coronary de novo lesions. Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after bare-metal stenting (BMS). The purpose is to assess the feasibility, safety and efficacy of the Lutonix Catheter for treatment of de novo coronary artery stenosis using two distinct treatment strategies.

Being tested
Lutonix Paclitaxel-Coated Balloon
Keywords
de novo stenotic lesions
Medical subject headings
Coronary Stenosis

What participants receive

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

  • Lutonix Paclitaxel-Coated BalloonDevice

    Also called Drug Coated Balloon

    Percutaneous transluminal coronary angioplasty (PCTA)

Study groups in NCT00934752
Study groupRoleWhat they receive
Lutonix CatheterExperimentalNot described
Receives: Device: Lutonix Paclitaxel-Coated Balloon

What is being measured

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

  1. Mean percent stent volume obstruction as measured by optical coherence tomography (OCT)

    Measured: 6 months

Secondary outcomes (4)

  1. Stent Malposition

    Measured: 6 Months

  2. Minimal Lumen Area

    Measured: 6 Months

  3. Stent Symmetry

    Measured: 6 Months

  4. Stent Expansion

    Measured: 6 Months

Timeline

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

  1. First posted8 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionApr 2010
  4. Study completionJan 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00934752
Sponsor's protocol ID
CL0013-01
Status last verified
Jan 2017
First submitted
6 Jul 2009
Last updated
16 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.

    PubMed 8041413

  • Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME; TAXUS II Study Group. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003 Aug 19;108(7):788-94. doi: 10.1161/01.CIR.0000086926.62288.A6. Epub 2003 Aug 4.

    PubMed 12900339

  • Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.

    PubMed 17470709

  • Eisenstein EL, Anstrom KJ, Kong DF, Shaw LK, Tuttle RH, Mark DB, Kramer JM, Harrington RA, Matchar DB, Kandzari DE, Peterson ED, Schulman KA, Califf RM. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA. 2007 Jan 10;297(2):159-68. doi: 10.1001/jama.297.2.joc60179. Epub 2006 Dec 5.

    PubMed 17148711

  • Acute platelet inhibition with abciximab does not reduce in-stent restenosis (ERASER study). The ERASER Investigators. Circulation. 1999 Aug 24;100(8):799-806. doi: 10.1161/01.cir.100.8.799.

    PubMed 10458714

  • Erbel R, Haude M, Hopp HW, Franzen D, Rupprecht HJ, Heublein B, Fischer K, de Jaegere P, Serruys P, Rutsch W, Probst P. Coronary-artery stenting compared with balloon angioplasty for restenosis after initial balloon angioplasty. Restenosis Stent Study Group. N Engl J Med. 1998 Dec 3;339(23):1672-8. doi: 10.1056/NEJM199812033392304.

    PubMed 9834304

  • Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.

    PubMed 8041414

  • Gonzalo N, Garcia-Garcia HM, Serruys PW, Commissaris KH, Bezerra H, Gobbens P, Costa M, Regar E. Reproducibility of quantitative optical coherence tomography for stent analysis. EuroIntervention. 2009 Jun;5(2):224-32. doi: 10.4244/eijv5i2a35.

    PubMed 19527980

  • 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

  • Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.

    PubMed 16814667

  • King SB 3rd, Smith SC Jr, Hirshfeld JW Jr, Jacobs AK, Morrison DA, Williams DO, Feldman TE, Kern MJ, O'Neill WW, Schaff HV, Whitlow PL; ACC/AHA/SCAI; Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):172-209. doi: 10.1016/j.jacc.2007.10.002. No abstract available.

    PubMed 18191745

  • Lee MS, Pessegueiro A, Zimmer R, Jurewitz D, Tobis J. Clinical presentation of patients with in-stent restenosis in the drug-eluting stent era. J Invasive Cardiol. 2008 Aug;20(8):401-3.

    PubMed 18688064

  • Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007 Mar 8;356(10):1020-9. doi: 10.1056/NEJMoa067731. Epub 2007 Feb 12.

    PubMed 17296821

  • Lansky AJ, Popma JJ, Cutlip D, Ho KK, Abizaid AS, Saucedo J, Zhang Y, Senerchia C, Kuntz RE, Leon MB, Baim DS. Comparative analysis of early and late angiographic outcomes using two quantitative algorithms in the Balloon versus Optimal Atherectomy Trial (BOAT). Am J Cardiol. 1999 Jun 15;83(12):1611-6. doi: 10.1016/s0002-9149(99)00166-6.

    PubMed 10392863

  • Gutierrez-Chico JL, Wykrzykowska J, Nuesch E, van Geuns RJ, Koch KT, Koolen JJ, di Mario C, Windecker S, van Es GA, Gobbens P, Juni P, Regar E, Serruys PW. Vascular tissue reaction to acute malapposition in human coronary arteries: sequential assessment with optical coherence tomography. Circ Cardiovasc Interv. 2012 Feb 1;5(1):20-9, S1-8. doi: 10.1161/CIRCINTERVENTIONS.111.965301. Epub 2012 Feb 7.

    PubMed 22319063

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lutonix Paclitaxel-Coated Balloon in people with Coronary Artery Stenosis, run by C. R. Bard at 3 sites in Netherlands.

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 18 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 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Mean percent stent volume obstruction as measured by optical coherence tomography (OCT) (time frame: 6 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 NCT00934752, which also lists 16 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 16 Jan 2017; AzTrials last refreshed its copy on 3 Nov 2026.

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