Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02198105
Status:
UNKNOWN
Last Update Posted:
2016-07-22
First Post:
2014-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
Sponsor:
Caritasklinik St. Theresia
Organization:
Study Overview
Official Title:
Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEBTRAK
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: