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Peripheral Arterial DiseaseDONDNCT02927574

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

An observational study of Peripheral Arterial Disease and Intermittent Claudication, run by Jena University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DCB and POBA
Type of treatment
Medical device
How many people
1,400 participants
Where
No sites listed yet
Study dates
Jul 2016to Sep 2017
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with intermittent claudication due to de novo femoropopliteal peripheral arterial disease.

Who may be able to join

  • 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)

Who cannot join

  • 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)

About this study

Official 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

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.

Read the detailed description

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.

Being tested
DCB, POBA
Keywords
drug-coated balloon angioplasty, angioplasty, plain old balloon angioplasty, peripheral arterial disease, intermittent claudication, systematic review, meta-analysis, Paclitaxel
Medical subject headings
Peripheral Arterial Disease, Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCBDevice

  • POBADevice

Study groups in NCT02927574
Study groupRoleWhat they receive
DCBTreatment with Paclitaxel drug-coated balloon angioplasty (DCB)
Receives: Device: DCB
POBATreatment with plain old balloon angioplasty (POBA)
Receives: Device: POBA

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 12 months

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

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

    Measured: 24 months

Secondary outcomes (7)

  1. Primary Patency (PP)

    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.]

    Measured: 12 and 24 months

  2. Secondary Patency (SP)

    freedom from binary restenosis after

    1. single repeated endovascular revascularization or
    2. 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.]

    Measured: 12 and 24 months

  3. Late Lumen Loss (LLL)

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

    Measured: 6 and 12 months

  4. ABI

    Ankle-Brachial-Index

    Measured: 12 and 24 months

  5. Rutherford-Becker Classification

    Clinical stage of disease according to Rutherford-Becker Classification

    Measured: 12 and 24 months

  6. Functional outcome

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

    Measured: 12 and 24 months

  7. Quality of Life (QoL)

    Quality of Life outcome eg. EQ5D

    Measured: 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
1,400 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02927574
Sponsor's protocol ID
IDIR/005/2016
Acronym
DOND
Status last verified
Mar 2020
First submitted
1 Sep 2016
Last updated
10 Mar 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease and Intermittent Claudication, run by Jena University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02927574.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.

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