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

In-Stent Restenosis Clinical Trial

— PERVIDEO I  

Official title:

A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916279
• Other study ID #: CL0010-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 4, 2009
• Last updated: November 17, 2015
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2015
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• In-Stent Restenosis

Intervention

Device:
• Lutonix Paclitaxel-Coated Balloon
PTCA

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis	Aalst
Germany	Kerckhoff Klinik	Bad Nauheim
Germany	Westdeutsches Herzzentrum Essen	Essen
Germany	Alte Clinic Center for Cardiology	Hamburg
Germany	Herzzentrum Leipzig GmbH	Leipzig
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Catherina Ziekenhuis	Eindhoven
Netherlands	Sint Antonius Ziehenhuis	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands, 

References & Publications (7)

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. Epub 2006 Mar 12. — View Citation

Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schühlen H, Schmitt C, Dirschinger J, Schömig 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. — View Citation

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm 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. Epub 2006 Nov 13. — View Citation

Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. Epub 2004 Aug 9. — View 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. — View 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. — View 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. Epub 2006 Mar 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Diameter Stenosis (%DS) in the Analysis Segment		6 months	No
Primary	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	No
Secondary	Late Lumen Loss	Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).	6 months	No
Secondary	MACE Rate	Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).	30 Days	Yes
Secondary	Binary Restenosis	Subjects with percent diameter stenosis >50% in the analysis segment.	6 Months	No