PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis

NCT00916279 | Completed Phase 1 Results DMC

• 1 other identifier: CL0010-01
• Study Type: interventional
• Target: 41
• Locations: 3 countries
• Sites: 8

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.

Conditions

In-Stent Restenosis

Keywords

Bare Metal In-Stent Restenosis; Paclitaxel Coated Balloon Catheter; Drug Coated Balloon; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Percent Diameter Stenosis (%DS) in the Analysis Segment

  6 months

• Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months

  Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.

  6 Months

Secondary Outcomes (3)

• Late Lumen Loss

  6 months

• MACE Rate

  30 Days

• Binary Restenosis

  6 Months

Study Arms (1)

Lutonix Catheter

EXPERIMENTAL

Device: Lutonix Paclitaxel-Coated Balloon

Interventions

Lutonix Paclitaxel-Coated Balloon DEVICE

PTCA

Also known as: Drug Coated Balloon

Lutonix Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (8)

Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, Belgium

Location

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Location

Westdeutsches Herzzentrum Essen

Essen, Germany

Location

Alte Clinic Center for Cardiology

Hamburg, 22527, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Catherina Ziekenhuis

Eindhoven, Netherlands

Location

Sint Antonius Ziehenhuis

Nieuwegein, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 15302790 BACKGROUND

• 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.

  PMID: 16864669 BACKGROUND

• 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.

  PMID: 16531618 BACKGROUND

• 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.

  PMID: 17101615 BACKGROUND

• 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.

  PMID: 16531619 BACKGROUND

• 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.

  PMID: 8041413 BACKGROUND

• 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.

  PMID: 15644543 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Chris Barry
• Organization: Lutonix Inc. a subsidiary of C.R. Bard

LutonixResearch@crbard.com

763-445-2352

Study Officials

• Laura Mauri, MD

  Brigham & Women's Hospital, Boston, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 9, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2011
• Last Updated: February 27, 2017
• Results First Posted: December 21, 2015

Record last verified: 2017-01

Locations

DE (4); BE (1); NL (3)