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

NCT ID: NCT00916279

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lutonix Catheter

Group Type: EXPERIMENTAL

Lutonix Paclitaxel-Coated Balloon

Intervention Type: DEVICE

PTCA

Interventions

Lutonix Paclitaxel-Coated Balloon

PTCA

Intervention Type: DEVICE

Other Intervention Names

Drug Coated Balloon

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Mauri, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham & Women's Hospital, Boston, MA

Locations

Onze Lieve Vrouw Ziekenhuis

Aalst, , Belgium

Kerckhoff Klinik

Bad Nauheim, , Germany

Westdeutsches Herzzentrum Essen

Essen, , Germany

Alte Clinic Center for Cardiology

Hamburg, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Academic Medical Center

Amsterdam, , Netherlands

Catherina Ziekenhuis

Eindhoven, , Netherlands

Sint Antonius Ziehenhuis

Nieuwegein, , Netherlands

Countries

Belgium; Germany; Netherlands

References

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

CL0010-01

Identifier Type: -

Identifier Source: org_study_id