Clinical trial NCT02198105: Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
Official title: Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Artery Disease
Femoropoliteal Stenosis/Occlusion
Cutting-balloon
Drug-coated-balloon
Keywords: PAD
femoropoliteal stenosis/occlusion
cutting-balloon
drug-coated-balloon
Lead sponsor: Caritasklinik St. Theresia
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion.

Brief 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).

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* peripheral artery disease (PAD) with femoro-popliteal stenosis \>70% or occlusion (vessel diameter 4-6mm)
* age 18-99
* informed consent

Exclusion Criteria:

* proximal / iliacal stenosis
* stenosis/occlusion of all arteries below the knee

Primary outcomes:
measure: Clinically driven target lesion revascularization (TLR)
timeFrame: 6 months
Secondary outcomes:
measure: clinically driven target vessel revascularization (TVR)
timeFrame: 6 months
measure: Binary restenosis
timeFrame: 6 months
measure: Change in Ankle Brachial Index (ABI)
timeFrame: 6 months
measure: Change in Rutherford-classification
timeFrame: 6 months
measure: major cardiac adverse events
timeFrame: 6 months
measure: Amputation
timeFrame: 6 months
measure: clinically driven target vessel revascularization (TVR)
timeFrame: 12 months
measure: Clinically driven target lesion revascularization (TLR)
timeFrame: 12 months
measure: Binary restenosis
timeFrame: 12 months
measure: Change in Ankle Brachial Index (ABI)
timeFrame: 12 months
measure: Change in Rutherford-classification
timeFrame: 12 months
measure: major cardiac adverse events
timeFrame: 12 months
measure: Amputation
timeFrame: 12 months
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: CaritasKlinikum, St. Theresia
state: Saarland
Study officials:
affiliation: CaritasKlinikum, St. Theresia Saarbrücken, Germany
name: Magnus Baumhäkel, MD
role: PRINCIPAL_INVESTIGATOR
References: