CompletedNCT00934752Updated Jan 16, 2017

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

A Phase 1/2 interventional study of Lutonix Paclitaxel-Coated Balloon in Coronary Artery Stenosis, sponsored by C. R. Bard. Completed at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-16.

Sponsored by C. R. Bard (part of Becton, Dickinson and Company) · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 24
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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). 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.

Conditions studied

Coronary Artery Stenosis

Browse trials for

Coronary Stenosis 309

Keywords

de novo stenotic lesions

In context

Coronary Stenosis

309 studies on the registry are indexed under Coronary Stenosis; 64 are open to participants now.

This study's enrollment of 24 is below the median of 191 across 165 interventional studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

C. R. Bard is the lead sponsor of 117 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 13 (76%) have results posted.

First submitted before C. R. Bard became part of Becton, Dickinson and Company.

Browse C. R. Bard studies →All Becton, Dickinson and Company studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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;
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.

Exclusion criteria

Exclusion Criteria:

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;
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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
Lutonix Catheter
Device: Lutonix Paclitaxel-Coated Balloon

Interventions

DeviceLutonix Paclitaxel-Coated Balloon
Percutaneous transluminal coronary angioplasty (PCTA)
Also known as: Drug Coated Balloon

What researchers measure

Primary outcomes

Mean percent stent volume obstruction as measured by optical coherence tomography (OCT)
Time frame: 6 months

Secondary outcomes

Stent Malposition
Time frame: 6 Months
Minimal Lumen Area
Time frame: 6 Months
Stent Symmetry
Time frame: 6 Months
Stent Expansion
Time frame: 6 Months

Study locations

3 sites

Academic Medical Center
Amsterdam, Netherlands
Catherina Zeikenhuis
Eindhoven, Netherlands
Thorax Center
Rotterdam, Netherlands

References and documents

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 ↗
Gutierrez-Chico JL, van Geuns RJ, Koch KT, Koolen JJ, Duckers H, Regar E, Serruys PW. Paclitaxel-coated balloon in combination with bare metal stent for treatment of de novo coronary lesions: an optical coherence tomography first-in-human randomised trial, balloon first vs. stent first. EuroIntervention. 2011 Oct 30;7(6):711-22. doi: 10.4244/EIJV7I6A114. PubMed 21986329 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2009, a primary completion of Apr 2010 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 6, 2009
First posted: Jul 8, 2009
Start: Jul 2009
Primary completionActual: Apr 2010
CompletionActual: Jan 2012
Last update: Jan 16, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00934752
Lead sponsor: C. R. Bard
Responsible party: Sponsor
First posted: Jul 8, 2009
Start date: Jul 2009
Primary completion: Apr 2010
Completion: Jan 2012
Last update: Jan 16, 2017

Study contacts

Prof. P.W.J C. Serruys, MD, PhD

principal investigator · Erasmus Universtiy Medical Center; Netherlands

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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