NCT01247402

Brief Summary

Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will be assigned to one of two study arms:

  1. 1.Treatment Arm: Paclitaxel eluting percutaneous transluminal angioplasty (PePTA)
  2. 2.Control Arm: standard percutaneous transluminal angioplasty (sPTA).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

2 active sites

Status
unknown

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

November 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 9, 2010

Status Verified

October 1, 2010

Enrollment Period

2 years

First QC Date

November 23, 2010

Last Update Submit

December 8, 2010

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial diseasein-stent restenosisdrug eluting balloon

Outcome Measures

Primary Outcomes (1)

  • primary patency rate

    Primary patency at 6 month follow up, defined as \<50%\* diameter stenosis as demonstrated by CDUS and CTA in the absence of clinically driven TLR (Target Lesion Revascularization) during follow-up. Clinically driven TLR defined as reintervention of the target lesion due to presence of a symptomatic \>50%\* diameter stenosis.

    6 months

Secondary Outcomes (1)

  • severe adverse events

    30 day

Study Arms (2)

Paclitaxel eluting balloon

ACTIVE COMPARATOR

Freeway 0.035 Paclitaxel eluting balloon (3 microgram Paclitaxel/mm2)

Device: drug eluting balloon angioplasty

Standard balloon angioplasty

ACTIVE COMPARATOR

standard balloon angioplasty

Device: standard balloon angioplasty

Interventions

drug eluting balloon angioplastyDEVICE

3 microgram Paclitaxel/mm2 on balloon, 60s application

Also known as: Freeway 0.035 balloon
Paclitaxel eluting balloon
standard balloon angioplastyDEVICE

standard balloon angioplasty

Standard balloon angioplasty

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 50 years
  • Patient legally authorized to provide written informed consent
  • Patient willing and likely to comply with the follow up schedule
  • Patient symptomatic Rutherford-Becker 2-5 (Fontaine II-IV)
  • In-stent restenosis in the SFA and P1 segment of the popliteal artery (PA)
  • Tibial run-off of at least 1 artery which however may be stenotic but amenable to PTA

You may not qualify if:

  • Patients unable to give informed consent
  • Patients enrolled in another study with any investigational drug or device
  • Major surgical procedures (not including minor amputations) within 30 days prior to this study or planned within 30 days of entry into this study
  • Pregnancy
  • Patients with any known allergy, hypersensitivity or intolerance to radiologic contrast media, ASA, Clopidogrel or Ticlopidine, Paclitaxel
  • Life expectancy of \< 1 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Angiology

Vienna, Vienna, 1090, Austria

RECRUITING

Cardiovascular and Interventional Radiology, AKH-MUW

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (1)

  • Kinstner CM, Lammer J, Willfort-Ehringer A, Matzek W, Gschwandtner M, Javor D, Funovics M, Schoder M, Koppensteiner R, Loewe C, Ristl R, Wolf F. Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery: 1-Year Results of the PACUBA Trial. JACC Cardiovasc Interv. 2016 Jul 11;9(13):1386-92. doi: 10.1016/j.jcin.2016.04.012.

    PMID: 27388828DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Johannes Lammer, MD

    Medical Univerity Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Lammer, MD

CONTACT

+431 40400johannes.lammer@akhwien.at

Johanna Moyses

CONTACT

+431 40400johanna.moyses@akhwien.at

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 24, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

December 9, 2010

Record last verified: 2010-10

Locations

AU(2)