Clinical trial NCT00916279: PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis
Official title: A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: In-Stent Restenosis
Keywords: Bare Metal In-Stent Restenosis
Paclitaxel Coated Balloon Catheter
Drug Coated Balloon
Coronary Artery Disease
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2009-06-09
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.


Eligibility criteria: 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;
* Previous history of native coronary bare metal stenting ≥60 days;
* LVEF ≥25%;
* Patient is an acceptable candidate for PTCA, stenting, and emergent CABG;
* Patient is willing to provide informed consent and comply with follow-up visits and testing schedule;
* Target lesion is in a native coronary with previous single bare metal stent; Stenosis is ≥50% and \<100% by visual estimate or QCA prior to defined pre-dilatation;
* Reference Vessel Diameter (RVD) is ≥2.5 and ≤3.25;
* Target lesion is ≤40 mm in length and can be treated in its entirety by no more than 2 contiguous Lutonix Catheters;
* Guidewire is able to cross lesion(s) and be placed in distal vessel prior to enrollment;
* Enrollment permitted after successful treatment of 1 to 2 non-study lesions in a single other non-study vessel. Successful treatment is defined as ≤30% residual stenosis with TIMI III flow and no evidence of dissection.

Exclusion Criteria:

* History of Stroke within past 6 months;
* History of MI or thrombolysis within 72 hours of randomization;
* History of previous target vessel perforation;
* Prior vascular brachytherapy;
* 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 in the Left Main or vessel ostium and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥2.5 mm;
* Target lesion is planned to be treated with something other than PTCA (i.e. stent, cutting balloon, atherectomy, VBT, etc.);
* Uncontrollable allergies to procedure medications, materials, or contrast;
* Patient has previous stent procedure with any drug-coated or drug eluting stent device in the target coronary vessel;
* Known sensitivity to paclitaxel or other antimitogenic agent;
* Patient has a stent sandwich (a stench previously deployed within another stent;
* Pre-procedure CKMB \>2x 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 anti-platelet therapy or it will need to be withdrawn for a planned procedure;
* The patient is currently participating in another investigational drug or device study that has not completed its primary endpoint or that clinically interferes with the endpoints of this study;

Primary outcomes:
measure: Percent Diameter Stenosis (%DS) in the Analysis Segment
timeFrame: 6 months
measure: Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Late Lumen Loss
timeFrame: 6 months
measure: MACE Rate
timeFrame: 30 Days
measure: Binary Restenosis
timeFrame: 6 Months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum Essen
city: Hamburg
country: Germany
facility: Alte Clinic Center for Cardiology
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Eindhoven
country: Netherlands
facility: Catherina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Ziehenhuis
Study officials:
affiliation: Brigham & Women's Hospital, Boston, MA
name: Laura Mauri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.
citation: Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. doi: 10.1148/radiol.2402051248.
citation: Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME; TAXUS V ISR Investigators. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA. 2006 Mar 15;295(11):1253-63. doi: 10.1001/jama.295.11.1253. Epub 2006 Mar 12.
citation: Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
citation: 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.
citation: 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.
citation: Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schuhlen H, Schmitt C, Dirschinger J, Schomig A; ISAR-DESIRE Study Investigators. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA. 2005 Jan 12;293(2):165-71. doi: 10.1001/jama.293.2.165.