Systematic Review and Meta-Analysis on DCB vs. POBA in De-novo Femoropopliteal Disease

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

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-09-30

Brief Summary

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Restenosis is still an issue after endovascular revascularization for femoropopliteal occlusive disease. One approach to reduce the rates of restenosis and reintervention is local application of Paclitaxel with drug-coated balloon angioplasty. The purpose is to conduct a systematic review and meta-analysis of randomized-controlled trials comparing on Drug-Coated Balloon angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in de-novo femoropopliteal disease.

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Detailed Description

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Peripheral arterial disease is the third leading entity of atherosclerosis. The femoropopliteal segment is affected in most patients. Endovascular revascularisation is one possible treatment option, but high rates of restenosis, especially in complex lesions, are a limiting factor. Bare-metal stents failed to show a long-term superiority in a Cochrane systematic review. Another approach to prevent restenosis is local delivery of an antiproliferative drug (e.g. Paclitaxel) via Drug-Coated Balloon Angioplasty. New studies did report their results since the publication of earlier meta-analyses. It's time for an up-to-date systematic review. Prior systematic reviews did not address risk of bias nor did they take differences in treatment strategy despite the used balloon catheter into consideration.Some previous reviews did compare results from different points in time, e.g. analysis of 6 months' results together with 24 months' results.

Conditions

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Peripheral Arterial Disease Intermittent Claudication

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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DCB

Treatment with Paclitaxel drug-coated balloon angioplasty (DCB)

DCB

Intervention Type DEVICE

POBA

Treatment with plain old balloon angioplasty (POBA)

POBA

Intervention Type DEVICE

Interventions

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DCB

Intervention Type DEVICE

POBA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Randomized controlled trials
* DCB vs. POBA
* focus on de-novo femoropopliteal lesions
* registration in a clinical trials registry
* available study protocol (either in clinical trial registry or published)

Exclusion Criteria

* non-randomized controlled trials
* focus on below-the-knee interventions
* focus on iliac artery interventions
* focus on treatment of critical limb ischemia
* focus on treatment of in-stent restenosis
* usage of additional devices except for bare-metal stent (e.g. atherectomy)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No