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Completed

NCT Number: NCT02927574

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

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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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DCB

Device

POBA

Device

Primary outcomes

  1. Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)

    Time frame: 12 months

    Freedom from repeated intervention of the index lesion (due to binary restenosis > 50% and/or recurrent symptoms)

  2. Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)

    Time frame: 24 months

    Freedom from repeated intervention of the index lesion (due to binary restenosis > 50% and/or recurrent symptoms)

Secondary outcomes

  1. Primary Patency (PP)

    Time frame: 12 and 24 months

    freedom from repeated intervention (FfTLR) and freedom from binary restenosis > 50% [comment: The metaanalysis compares the endpoints of different trials comparing DCB vs. POBA. The primary patency is a commonly used efficacy endpoint in those trials; information on this endpoint will be extracted from already published trial data.]

  2. Secondary Patency (SP)

    Time frame: 12 and 24 months

    freedom from binary restenosis after

    • single repeated endovascular revascularization or
    • no repeated Intervention [comment: The metaanalysis compares the endpoints of different trials comparing DCB vs. POBA. The secondary patency is another commonly used efficacy endpoint in those trials; information on this endpoint will be extracted from already published trial data.]

  3. Late Lumen Loss (LLL)

    Time frame: 6 and 12 months

    Difference of minimal lumen diameter at follow-up compared to minimal lumen diameter after index procedure

  4. ABI

    Time frame: 12 and 24 months

    Ankle-Brachial-Index

  5. Rutherford-Becker Classification

    Time frame: 12 and 24 months

    Clinical stage of disease according to Rutherford-Becker Classification

  6. Functional outcome

    Time frame: 12 and 24 months

    Functional result eg. Walking Impairment Questionnaire (WIQ) or treadmill test

  7. Quality of Life (QoL)

    Time frame: 12 and 24 months

    Quality of Life outcome eg. EQ5D

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Registry information

Official study title

Drug Or No Drug (DOND): Systematic Review and Meta-Analysis on Drug-Coated Balloon Angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in De-novo Femoropopliteal Disease

Acronym: DOND

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 7, 2016
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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