Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.

Peripheral Artery Disease Clinical Trial

— DEBTRAK  

Official title:

Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02198105
• Other study ID #: DEBTRAK-Registry
• Status: Active, not recruiting
• Phase: N/A
• First received: July 18, 2014
• Last updated: July 21, 2016
• Start date: May 2014
• Est. completion date: November 2016

Study information

• Verified date: July 2016
• Source: Caritasklinik St. Theresia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Saarland: Local ethical committee
• Study type: Observational [Patient Registry]

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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constriction, Pathologic
• Cutting-balloon
• Drug-coated-balloon
• Femoropoliteal Stenosis/Occlusion
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA
Interventional procedure: PTA with Cutting-Balloon (60-120 seconds). PTA with DC-Balloon (60 seconds). Technical success is defined as no recoil >30% no dissection >Type B no stenting >30% of lesion length.

Locations

Country	Name	City	State
Germany	CaritasKlinikum, St. Theresia	Saarbrücken	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Caritasklinik St. Theresia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically driven target lesion revascularization (TLR)	clinically driven target lesion revascularization	6 months	No
Secondary	clinically driven target vessel revascularization (TVR)	TVR	6 months	No
Secondary	Binary restenosis	Peak Systolic velocity (PSV) >2.4	6 months	No
Secondary	Change in Ankle Brachial Index (ABI)	Change in ankle brachial index from baseline.	6 months	No
Secondary	Change in Rutherford-classification	Change in Rutherford-Classification from Baseline (I-VI)	6 months	No
Secondary	major cardiac adverse events	myocardial infarction, stroke, death, cardiovascular death	6 months	Yes
Secondary	Amputation		6 months	Yes
Secondary	clinically driven target vessel revascularization (TVR)		12 months	No
Secondary	Clinically driven target lesion revascularization (TLR)		12 months	No
Secondary	Binary restenosis		12 months	No
Secondary	Change in Ankle Brachial Index (ABI)		12 months	No
Secondary	Change in Rutherford-classification		12 months	No
Secondary	major cardiac adverse events	myocardial infarction, stroke, death, cardiovascular death	12 months	Yes
Secondary	Amputation		12 months	Yes