NCT02183194

Brief Summary

The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

June 25, 2014

Last Update Submit

February 1, 2016

Conditions

Dysfunctional AV GraftDysfunctional AV Fistula

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Primary Patency

    Target Lesion Primary Patency (TLPP): The interval following index procedure intervention until the next reintervention of the target lesion or access thrombosis.

    6 months

Secondary Outcomes (7)

  • Target Lesion Primary Patency (TLPP)

    12 months

  • Access circuit primary patency

    6 and 12 months

  • Abandonment of permanent access in the index extremity

    6 and 12 months

  • Number of interventions required to maintain target lesion patency

    6 and 12 months

  • Number of interventions, required to maintain access circuit patency

    6 and 12 months

  • +2 more secondary outcomes

Study Arms (1)

Lutonix Paclitaxel Drug Coated Balloon

EXPERIMENTAL
Device: Lutonix Paclitaxel Drug Coated Balloon

Interventions

Lutonix Paclitaxel Drug Coated BalloonDEVICE
Lutonix Paclitaxel Drug Coated Balloon

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF)
  • Hemodialysis access on the arm presenting with any clinical abnormalities as defined in the K/DOQI guidelines
  • Native AV fistula or synthetic AV graft has been implanted ≥30 days
  • Target de novo or non-stented restenotic lesion(s) consisting of a \>50% stenosis by visual estimate. Successful treatment of non target lesion(s) (residual stenosis \<30% by visual estimate) without procedural complication by standard of care
  • Successful predilatation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon
  • Intended target lesion(s) (maximum of 2) can be treated
  • No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the treatment

You may not qualify if:

  • Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children
  • Known contraindication (including allergic reaction) or sensitivity to contrast media, ASA, clopidogrel, ticlopidine, paclitaxel (mild to severe cases), that cannot be adequately managed with pre-and post-procedure medication
  • Life expectancy \<12months
  • Scheduled for kidney transplant or peritoneal dialysis in the next 12months;
  • Thrombosed access
  • Stent in the target treatment area
  • Blood coagulative disorder, sepsis, or current AV access infection
  • Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study NOTE: Enrollment in another investigational drug, biologic, or device study during the follow- up period is not allowed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

LKH-Univ. Klinikum Graz

Graz, 8036, Austria

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Universitätsklinikum Köln AöR

Cologne, 50937, Germany

Location

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, 23538, Germany

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2014

First Posted

July 8, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

DE(2)AU(2)