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

NCT02927574 | Completed

• 1 other identifier: IDIR/005/2016
• Study Type: observational
• Target: 1,400
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Keywords

drug-coated balloon angioplasty; angioplasty; plain old balloon angioplasty; peripheral arterial disease; intermittent claudication; systematic review; meta-analysis; Paclitaxel

Outcome Measures

Primary Outcomes (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)

  12 months

• 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)

  24 months

Secondary Outcomes (7)

• Primary Patency (PP)

  12 and 24 months

• Secondary Patency (SP)

  12 and 24 months

• Late Lumen Loss (LLL)

  6 and 12 months

• ABI

  12 and 24 months

• Rutherford-Becker Classification

  12 and 24 months

Study Arms (2)

DCB

Treatment with Paclitaxel drug-coated balloon angioplasty (DCB)

Device: DCB

POBA

Treatment with plain old balloon angioplasty (POBA)

Device: POBA

Interventions

DCB DEVICE

DCB

POBA DEVICE

POBA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jena University Hospital: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulf Teichgräber, Prof.

  University Hospital Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: October 7, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 10, 2020

Record last verified: 2020-03