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Clinical Trial Summary

Observational registry including patients with peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).


Clinical Trial Description

The registry includes consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).

Interventional procedure:

1. PTA with Cutting-Balloon (60-120 seconds).

2. PTA with Drug-Coated-Balloon (60 seconds).

Technical success is defined as

1. no recoil >30%

2. no dissection >Type B

3. no stenting >30% of lesion length.

Follow-up of patients after 6 months and 12 months (ABI, Rutherford-classification, MACE, TLR, TVR, Binary Restenosis). ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT02198105
Study type Observational [Patient Registry]
Source Caritasklinik St. Theresia
Contact
Status Active, not recruiting
Phase N/A
Start date May 2014
Completion date November 2016

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