Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis (PACIFIER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01083030
First received: March 4, 2010
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

The aim of the study is correlating efficacy of the treatment to the proportion of paclitaxel-dose supplied by the catheter. Forty-five patients each will be treated by paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in the superficial femoral or popliteal artery, main exclusion criteria are related to the use of paclitaxel and the need for follow-up examinations. Either clinical or angiographic follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary endpoint is 6-month angiographic late lumen loss. Secondary endpoints are further angiographic and clinical efficacy and various safety criteria.


Condition Intervention Phase
Peripheral Artery Disease
Procedure: Percutaneous transluminal angioplasty (PTA)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • Late lumen loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Efficacy of paclitaxel coated percutaneous transluminal angioplasty (PTA) balloons in inhibiting restenosis of femoropopliteal arteries (late lumen loss)


Secondary Outcome Measures:
  • Angiographic and clinical efficacy measures [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Various angiographic and clinical efficacy measures, safety and tolerance of paclitaxel coated PTA balloons in inhibiting restenosis of femoropopliteal arteries:

    1. Target lesion revascularization (Target lesion revascularization is defined as any reintervention or artery bypass graft surgery involving the target lesion.)
    2. Change in Rutherford stage compared to pretreatment
    3. Major amputations at the index limb
    4. Pre-defined event free survival


Estimated Enrollment: 90
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Conventional PTA
Angioplasty of SFA with uncoated balloon catheters
Procedure: Percutaneous transluminal angioplasty (PTA)
Angioplasty of superficial femoral artery (SFA)
Other Names:
  • uncoated PTA
  • drug coated PTA
Active Comparator: Drug coated balloon
Angioplasty of SFA with paclitaxel-coated balloon catheters
Procedure: Percutaneous transluminal angioplasty (PTA)
Angioplasty of superficial femoral artery (SFA)
Other Names:
  • uncoated PTA
  • drug coated PTA

Detailed Description:

Paclitaxel-coated balloons have been shown to reduce late lumen loss, restenosis rates and the need for repeat target lesion revascularization compared to conventional uncoated balloon catheters. The aim of the study is correlating efficacy of the treatment to the proportion of paclitaxel-dose supplied by the catheter. To this end paclitaxel loss of catheters in the introductory sheaths and residual paclitaxel on used balloons will be determined and correlated to individual data indicating inhibition of neointimal proliferation. According to the study protocol 45 patients each will be treated by paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in the superficial femoral or popliteal artery, 3 to 30 cm of length; beyond common contraindications against PTA main exclusion criteria are related to the use of paclitaxel and the need for follow-up examinations. Patients will be blinded against treatment. Blinding of investigators after assignment of a patient to a treatment is not possible due to differences in the appearance of coated and uncoated catheters. Either clinical or angiographic follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary endpoint is 6-month angiographic late lumen loss evaluated by a blinded independent core lab. Secondary endpoints are interventional success rate, restenosis rates, minimal lumen diameter, target lesion revascularization, change in Rutherford class, change in ankle-brachial-index, major amputations, a composite safety endpoint (defined as MAE =death of any cause, target limb amputation, clinically / DUS driven TLR) and all kinds of serious adverse events possibly related to the treatment.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with PAOD, Rutherford stage 2-5, Occlusion or stenosis >70% in diameter of at least 3 cm length in the superficial femoral artery and/ or popliteal artery

Exclusion Criteria:

  • Acute thrombus or aneurysm in the index limb/ vessel
  • Doubts in the willingness or capability of the patient to allow follow up examination
  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: NCT01083030

Locations
Germany
Martin-Luther-Hospital Berlin
Berlin, Germany, 14193
Ev. Hubertus Hospital Berlin
Berlin, Germany, 14129
Vivantes - Klinikum Neukölln
Berlin, Germany, 12351
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Michael Werk, MD Martin-Luther-Hospital Berlin
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT01083030     History of Changes
Other Study ID Numbers: Pac 12
Study First Received: March 4, 2010
Last Updated: July 25, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Saarland:
pAVK
PTA
drug coated balloon

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

ClinicalTrials.gov processed this record on August 01, 2014