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In-Stent RestenosisPhase 1/2PERVIDEO INCT00916279

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

A Phase 1/2 study testing Lutonix Paclitaxel-Coated Balloon in people with In-Stent Restenosis, run by C. R. Bard at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
In-Stent Restenosis
What is being tested?
Lutonix Paclitaxel-Coated Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
8 sitesin 3 countries
Study dates
Jun 2009to Dec 2011
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 11Show fewer
  • 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.

Who cannot join

  • 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;
Show all 19Show fewer
  • 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;

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Germany4 sites

  • Kerckhoff Klinik

    Bad Nauheim, 61231

  • Westdeutsches Herzzentrum Essen

    Essen

  • Alte Clinic Center for Cardiology

    Hamburg, 22527

  • Herzzentrum Leipzig GmbH

    Leipzig

Other trials in Germany

Netherlands3 sites

  • Academic Medical Center

    Amsterdam

  • Catherina Ziekenhuis

    Eindhoven

  • Sint Antonius Ziehenhuis

    Nieuwegein

Other trials in Netherlands

Belgium1 site

  • Onze Lieve Vrouw Ziekenhuis

    Aalst, 9300

Other trials in Belgium

About this study

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

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.

Being tested
Lutonix Paclitaxel-Coated Balloon
Keywords
Bare Metal In-Stent Restenosis, Paclitaxel Coated Balloon Catheter, Drug Coated Balloon, Coronary Artery Disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lutonix Paclitaxel-Coated BalloonDevice

    Also called Drug Coated Balloon

    PTCA

Study groups in NCT00916279
Study groupRoleWhat they receive
Lutonix CatheterExperimentalNot described
Receives: Device: Lutonix Paclitaxel-Coated Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Diameter Stenosis (%DS) in the Analysis Segment

    Measured: 6 months

  2. 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.

    Measured: 6 Months

Secondary outcomes (3)

  1. 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).

    Measured: 6 months

  2. MACE Rate

    Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).

    Measured: 30 Days

  3. Binary Restenosis

    Subjects with percent diameter stenosis >50% in the analysis segment.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionOct 2010
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00916279
Sponsor's protocol ID
CL0010-01
Acronym
PERVIDEO I
Status last verified
Jan 2017
First submitted
4 Jun 2009
Last updated
27 Feb 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15302790

  • 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.

    PubMed 16864669

  • 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.

    PubMed 16531618

  • 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.

    PubMed 17101615

  • 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

  • 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

  • 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.

    PubMed 15644543

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lutonix Paclitaxel-Coated Balloon in people with In-Stent Restenosis, run by C. R. Bard at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Diameter Stenosis (%DS) in the Analysis Segment (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00916279, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.

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