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

March 4, 2010
July 25, 2013
March 2010
August 2011   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01083030 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis
Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Artery Disease
Procedure: Percutaneous transluminal angioplasty (PTA)
Angioplasty of superficial femoral artery (SFA)
Other Names:
  • uncoated PTA
  • drug coated PTA
  • Placebo Comparator: Conventional PTA
    Angioplasty of SFA with uncoated balloon catheters
    Intervention: Procedure: Percutaneous transluminal angioplasty (PTA)
  • Active Comparator: Drug coated balloon
    Angioplasty of SFA with paclitaxel-coated balloon catheters
    Intervention: Procedure: Percutaneous transluminal angioplasty (PTA)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01083030
Pac 12
Yes
University Hospital, Saarland
University Hospital, Saarland
Not Provided
Principal Investigator: Michael Werk, MD Martin-Luther-Hospital Berlin
University Hospital, Saarland
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP