Paclitaxel Balloon Versus Standard Balloon in In-stent Restenoses of the Superficial Femoral Artery (PACUBA I Trial) (PACUBA 1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01247402
First received: November 23, 2010
Last updated: December 8, 2010
Last verified: October 2010
  Purpose

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

Purpose:

To evaluate the morphologic and clinical efficacy of Paclitaxel eluting percutaneous transluminal angioplasty (PePTA) for the reduction of restenosis in SFA and PA stents compared to standard percutaneous transluminal angioplasty (sPTA).


Condition Intervention Phase
Peripheral Arterial Disease
Device: drug eluting balloon angioplasty
Device: standard balloon angioplasty
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Monocenter Randomized Clinical Trial of PAClitaxel drUg-eluting BAlloon Versus Standard Percutaneous Transluminal Angioplasty to Reduce Restenosis in Patients With In-stent Stenoses in the Superficial Femoral and Proximal Popliteal Artery

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • primary patency rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • severe adverse events [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paclitaxel eluting balloon
Freeway 0.035 Paclitaxel eluting balloon (3 microgram Paclitaxel/mm2)
Device: drug eluting balloon angioplasty
3 microgram Paclitaxel/mm2 on balloon, 60s application
Other Name: Freeway 0.035 balloon
Active Comparator: Standard balloon angioplasty
standard balloon angioplasty
Device: standard balloon angioplasty
standard balloon angioplasty

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All criteria 1-6 should apply for inclusion.

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

Exclusion Criteria:

  1. Patients unable to give informed consent
  2. Patients enrolled in another study with any investigational drug or device
  3. Major surgical procedures (not including minor amputations) within 30 days prior to this study or planned within 30 days of entry into this study
  4. Pregnancy
  5. Patients with any known allergy, hypersensitivity or intolerance to radiologic contrast media, ASA, Clopidogrel or Ticlopidine, Paclitaxel
  6. Life expectancy of < 1 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247402

Contacts
Contact: Johannes Lammer, MD +431 40400 ext 5802 johannes.lammer@akhwien.at
Contact: Johanna Moyses +431 40400 ext 6742 johanna.moyses@akhwien.at

Locations
Austria
Cardiovascular and Interventional Radiology, AKH-MUW Recruiting
Vienna, Austria, 1090
Contact: Johannes Lammer, MD    +431 40400 ext 5802    johannes.lammer@akhwien.at   
Contact: Johanna Moyses    +431 40400 ext 6742    johanna.moyses@akhwien.at   
Sub-Investigator: Renate Koppensteiner, MD         
Sub-Investigator: Maria Schoder, MD         
Sub-Investigator: Andrea Willfort-Ehringer MD         
Sub-Investigator: Michael Gschwandtner, MD         
Sub-Investigator: Martin Funovics, MD         
Sub-Investigator: Christian Loewe, MD         
Sub-Investigator: Florian Wolf, MD         
Sub-Investigator: Christina Plank, MD         
Sub-Investigator: Wolfgang Matzek, MD         
Angiology Recruiting
Vienna, Austria, 1090
Contact: Renate Koppensteiner, MD    +431 40400 ext 4671    renate.koppensteiner@meduniwien.ac.at   
Sub-Investigator: Andrea Willfort-Ehringer, MD         
Sub-Investigator: Michael Gschwandtner, MD         
Sub-Investigator: Martin Schillinger, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Johannes Lammer, MD Medical Univerity Vienna
  More Information

No publications provided

Responsible Party: Johannes Lammer MD, Professor of Radiology, Department of Radiology, Cardiovascular and Interventional Radiology
ClinicalTrials.gov Identifier: NCT01247402     History of Changes
Other Study ID Numbers: PACUBA 1
Study First Received: November 23, 2010
Last Updated: December 8, 2010
Health Authority: Austria: Medical University Vienna

Keywords provided by Medical University of Vienna:
peripheral arterial disease
in-stent restenosis
drug eluting balloon

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014