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Peripheral Artery DiseasePhase 3PACIFIERNCT01083030

Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

A Phase 3 study testing Percutaneous transluminal angioplasty (PTA) and DCB in people with Peripheral Artery Disease, run by University Hospital, Saarland at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Peripheral Artery Disease
What is being tested?
Percutaneous transluminal angioplasty (PTA) and DCB
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
3 sitesGermany
Study dates
Mar 2010to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Vivantes - Klinikum Neukölln

    Berlin, 12351

  • Ev. Hubertus Hospital Berlin

    Berlin, 14129

  • Martin-Luther-Hospital Berlin

    Berlin, 14193

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Percutaneous transluminal angioplasty (PTA), DCB
Keywords
pAVK, PTA, drug coated balloon
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous transluminal angioplasty (PTA)Device

    Also called uncoated PTA

    Angioplasty of superficial femoral artery (SFA)

  • DCBCombination product

    Drug Coated Balloon Angioplasty

Study groups in NCT01083030
Study groupRoleWhat they receive
Conventional PTAActive comparatorAngioplasty of SFA with uncoated balloon catheters
Receives: Device: Percutaneous transluminal angioplasty (PTA)
Drug coated balloonExperimentalAngioplasty of SFA with paclitaxel-coated balloon catheters
Receives: Combination Product: DCB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Late lumen loss

    Efficacy of paclitaxel coated percutaneous transluminal angioplasty (PTA) balloons in inhibiting restenosis of femoropopliteal arteries (late lumen loss)

    Measured: 6 months

Secondary outcomes (1)

  1. Angiographic and clinical efficacy measures

    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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionAug 2011
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01083030
Sponsor's protocol ID
Pac 12
Acronym
PACIFIER
Status last verified
May 2023
First submitted
4 Mar 2010
Last updated
6 May 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2008 Oct;97(10):773-81. doi: 10.1007/s00392-008-0682-5. Epub 2008 Jun 5.

    PubMed 18536865

  • Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.

    PubMed 18272892

  • Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.

    PubMed 17101615

  • Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.

    PubMed 15302790

  • Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.

    PubMed 18779447

  • Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.

    PubMed 42573020

  • Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, Hanninen EL. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012 Dec;5(6):831-40. doi: 10.1161/CIRCINTERVENTIONS.112.971630. Epub 2012 Nov 27.

    PubMed 23192918

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Percutaneous transluminal angioplasty (PTA) and DCB in people with Peripheral Artery Disease, run by University Hospital, Saarland at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late lumen loss (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01083030, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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