This trial is active, not recruiting.

Conditions peripheral arterial disease, intermittent claudication
Treatments dcb, poba
Sponsor Jena University Hospital
Start date July 2016
End date October 2016
Trial size 1400 participants
Trial identifier NCT02927574, IDIR/005/2016


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.

United States No locations recruiting
Other countries No locations recruiting

Primary Outcomes

Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)
time frame: 12 months
Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR)
time frame: 24 months

Secondary Outcomes

Primary Patency (PP)
time frame: 12 and 24 months
Secondary Patency (SP)
time frame: 12 and 24 months
Late Lumen Loss (LLL)
time frame: 6 and 12 months
time frame: 12 and 24 months
Rutherford-Becker Classification
time frame: 12 and 24 months
Functional outcome
time frame: 12 and 24 months
Quality of Life (QoL)
time frame: 12 and 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Principal investigator Ulf Teichgräber, Prof.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Jena University Hospital.