Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional PTA

Angioplasty of SFA with uncoated balloon catheters

Group Type ACTIVE_COMPARATOR

Percutaneous transluminal angioplasty (PTA)

Intervention Type DEVICE

Angioplasty of superficial femoral artery (SFA)

Drug coated balloon

Angioplasty of SFA with paclitaxel-coated balloon catheters

Group Type EXPERIMENTAL

DCB

Intervention Type COMBINATION_PRODUCT

Drug Coated Balloon Angioplasty

Interventions

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Percutaneous transluminal angioplasty (PTA)

Angioplasty of superficial femoral artery (SFA)

Intervention Type DEVICE

DCB

Drug Coated Balloon Angioplasty

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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uncoated PTA

Eligibility Criteria

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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