Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

Peripheral Artery Disease Clinical Trial

— PACIFIER  

Official title:

Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083030
• Other study ID #: Pac 12
• Status: Completed
• Phase: Phase 3
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2023
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Percutaneous transluminal angioplasty (PTA)
Angioplasty of superficial femoral artery (SFA)

Combination Product:
• DCB
Drug Coated Balloon Angioplasty

Locations

Country	Name	City	State
Germany	Ev. Hubertus Hospital Berlin	Berlin
Germany	Martin-Luther-Hospital Berlin	Berlin
Germany	Vivantes - Klinikum Neukölln	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Circulation. 2008 Oct 14;118(16):e670. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late lumen loss	Efficacy of paclitaxel coated percutaneous transluminal angioplasty (PTA) balloons in inhibiting restenosis of femoropopliteal arteries (late lumen loss)	6 months
Secondary	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: 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	6 months