Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

NCT01083030 | Completed Phase 3 DMC

• 1 other identifier: Pac 12
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Peripheral Artery Disease

Keywords

pAVK; PTA; drug coated balloon

Outcome Measures

Primary Outcomes (1)

• Late lumen loss

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

  6 months

Secondary Outcomes (1)

• Angiographic and clinical efficacy measures

  6 months

Study Arms (2)

Conventional PTA

ACTIVE COMPARATOR

Angioplasty of SFA with uncoated balloon catheters

Device: Percutaneous transluminal angioplasty (PTA)

Drug coated balloon

EXPERIMENTAL

Angioplasty of SFA with paclitaxel-coated balloon catheters

Combination Product: DCB

Interventions

Percutaneous transluminal angioplasty (PTA) DEVICE

Angioplasty of superficial femoral artery (SFA)

Also known as: uncoated PTA

Conventional PTA

DCB COMBINATION_PRODUCT

Drug Coated Balloon Angioplasty

Drug coated balloon

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Saarland: lead

Study Sites (3)

Vivantes - Klinikum Neukölln

Berlin, 12351, Germany

Location

Ev. Hubertus Hospital Berlin

Berlin, 14129, Germany

Location

Martin-Luther-Hospital Berlin

Berlin, 14193, Germany

Location

Related Publications (6)

• 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.

  PMID: 18536865 BACKGROUND

• 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.

  PMID: 18272892 BACKGROUND

• 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.

  PMID: 17101615 BACKGROUND

• 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.

  PMID: 15302790 BACKGROUND

• 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.

  PMID: 18779447 BACKGROUND

• 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.

  PMID: 23192918 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Michael Werk, MD

  Martin-Luther-Hospital Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 9, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2012
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

DE (3)