Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis (PACIFIER)
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ClinicalTrials.gov Identifier: NCT01083030 |
Recruitment Status :
Completed
First Posted : March 9, 2010
Last Update Posted : July 26, 2013
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Condition or disease | Intervention/treatment | Phase |
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Peripheral Artery Disease | Procedure: Percutaneous transluminal angioplasty (PTA) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | December 2012 |
Arm | Intervention/treatment |
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Placebo Comparator: Conventional PTA
Angioplasty of SFA with uncoated balloon catheters
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Procedure: Percutaneous transluminal angioplasty (PTA)
Angioplasty of superficial femoral artery (SFA)
Other Names:
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Active Comparator: Drug coated balloon
Angioplasty of SFA with paclitaxel-coated balloon catheters
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Procedure: Percutaneous transluminal angioplasty (PTA)
Angioplasty of superficial femoral artery (SFA)
Other Names:
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- Late lumen loss [ Time Frame: 6 months ]Efficacy of paclitaxel coated percutaneous transluminal angioplasty (PTA) balloons in inhibiting restenosis of femoropopliteal arteries (late lumen loss)
- Angiographic and clinical efficacy measures [ Time Frame: 6 months ]
Various angiographic and clinical efficacy measures, safety and tolerance of paclitaxel coated PTA balloons in inhibiting restenosis of femoropopliteal arteries:
- Target lesion revascularization (Target lesion revascularization is defined as any reintervention or artery bypass graft surgery involving the target lesion.)
- Change in Rutherford stage compared to pretreatment
- Major amputations at the index limb
- Pre-defined event free survival

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083030
Germany | |
Vivantes - Klinikum Neukölln | |
Berlin, Germany, 12351 | |
Ev. Hubertus Hospital Berlin | |
Berlin, Germany, 14129 | |
Martin-Luther-Hospital Berlin | |
Berlin, Germany, 14193 |
Principal Investigator: | Michael Werk, MD | Martin-Luther-Hospital Berlin |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital, Saarland |
ClinicalTrials.gov Identifier: | NCT01083030 |
Other Study ID Numbers: |
Pac 12 |
First Posted: | March 9, 2010 Key Record Dates |
Last Update Posted: | July 26, 2013 |
Last Verified: | July 2013 |
pAVK PTA drug coated balloon |
Peripheral Arterial Disease Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases |