NCT00930813

Brief Summary

The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2009

Typical duration for phase_1

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

December 21, 2015

Completed
Last Updated

December 21, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

June 30, 2009

Results QC Date

August 5, 2014

Last Update Submit

November 17, 2015

Conditions

AtherosclerosisVascular DiseaseArteriosclerosis

Keywords

Drug coated balloonSFA diseaseFemoropopliteal diseaseAngioplastyPADPaclitaxelTubulin modulatorsAntineoplastic AgentsMitosis ModulatorsBalloon angioplastyLocal drug deliveryRestenosisDrug-coated balloon

Outcome Measures

Primary Outcomes (1)

  • Angiographic Late Lumen Loss

    Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months.

    6 months

Secondary Outcomes (10)

  • Safety - Device Related Adverse Events

    30 days

  • Primary Patency of Treated Segment

    6, 12, 24 months

  • Target Lesion Revascularization

    6, 12, 24 months

  • Target Vessel Revascularization

    6, 12, 24 months

  • Device Success

    at procedure

  • +5 more secondary outcomes

Study Arms (2)

Lutonix Catheter

EXPERIMENTAL

Paclitaxel coated Balloon Catheter

Device: Lutonix Catheter

Standard uncoated Balloon Angioplasty Catheter

ACTIVE COMPARATOR

uncoated angioplasty balloon

Device: Standard uncoated Balloon Angioplasty Catheter

Interventions

Lutonix CatheterDEVICE

Paclitaxel Coated Balloon Catheter

Also known as: DCB, Drug coated balloon
Lutonix Catheter
Standard uncoated Balloon Angioplasty CatheterDEVICE

plain, uncoated angioplasty balloon catheter

Standard uncoated Balloon Angioplasty Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Criteria
  • Male or non-pregnant female ≥18 years of age.
  • Rutherford Clinical Category 2-5
  • Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen Angiographic Criteria
  • A single de novo or restenotic atherosclerotic lesion \>70% in the SFA or popliteal artery that is ≥4 cm and ≤15 cm in total length.
  • Reference vessel diameter ≥4 mm and ≤ 6mm
  • Successful wire crossing of lesion
  • A patent inflow artery free from significant lesion (\>50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions)

You may not qualify if:

  • Pregnant or planning on becoming pregnant in \< 2yrs
  • Live expectancy of \<2 years
  • Patient actively participating in another investigational device or drug study
  • History of hemorrhagic stroke within 3 months
  • Previous or planned surgical or interventional procedure within 30 days of index procedure
  • Chronic renal insufficiency with creatinine \>2.5 mg/L
  • Prior surgery of the target lesion
  • Inability to take required study medications
  • Anticipated use of IIb/IIIa inhibitor prior to randomization
  • Lesion length is \<4 cm or \>15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
  • Known inadequate distal outflow
  • Significant inflow disease
  • Acute or sub-acute thrombus in target vessel
  • Severe lesion calcification
  • Acute vessel occlusion or sudden symptom onset
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Sint Blasius

Dendermonde, Belgium

Location

Herz Zentrum

Bad Krozingen, Germany

Location

Jewish Hospital

Berlin, Germany

Location

St Katharenen Cardiovascular Center

Frankfurt, Germany

Location

Hamburg Unversity Cardiovascular Center

Hamburg, Germany

Location

Park Krankenhaus - University of Leipzig

Leipzig, Germany

Location

Universitätsklinikum

Magdeburg, Germany

Location

St. Franziskus

Münster, Germany

Location

Klinikum Rosenheim

Rosenheim, Germany

Location

Katharinenhospital

Stuttgart, Germany

Location

Related Publications (4)

  • Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.

    PMID: 18272892BACKGROUND

  • Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.

    PMID: 18779447BACKGROUND

  • Ouriel K, Adelman MA, Rosenfield K, Scheinert D, Brodmann M, Pena C, Geraghty P, Lee A, White R, Clair DG. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2515-2524. doi: 10.1016/j.jcin.2019.08.025. Epub 2019 Sep 28.

    PMID: 31575518DERIVED

  • Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.

    PMID: 24456716DERIVED

MeSH Terms

Conditions

AtherosclerosisVascular DiseasesArteriosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesCardiovascular Diseases

Results Point of Contact

Title
Chris Barry
Organization
Lutonix Inc. a subsidiary of C.R. Bard
LutonixResearch@crbard.com
763-445-2352

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2011

Last Updated

December 21, 2015

Results First Posted

December 21, 2015

Record last verified: 2015-11

Locations

BE(1)DE(9)