Peripheral Artery DiseaseDEBTRAKNCT02198105
Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
An observational study of Peripheral Artery Disease and Femoropoliteal Stenosis/Occlusion, run by Caritasklinik St. Theresia at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Femoropoliteal Stenosis/Occlusion, Cutting-balloon
- What is being tested?
- Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Nov 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion.
Who may be able to join
- peripheral artery disease (PAD) with femoro-popliteal stenosis >70% or occlusion (vessel diameter 4-6mm)
- age 18-99
- informed consent
Who cannot join
- proximal / iliacal stenosis
- stenosis/occlusion of all arteries below the knee
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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:
- PTA with Cutting-Balloon (60-120 seconds).
- PTA with Drug-Coated-Balloon (60 seconds).
Technical success is defined as
- no recoil >30%
- no dissection >Type B
- no stenting >30% of lesion length.
Follow-up of patients after 6 months and 12 months (ABI, Rutherford-classification, MACE, TLR, TVR, Binary Restenosis).
- Conditions
- Peripheral Artery Disease, Femoropoliteal Stenosis/Occlusion, Cutting-balloon, Drug-coated-balloon
- Being tested
- Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA
- Keywords
- PAD, femoropoliteal stenosis/occlusion, cutting-balloon, drug-coated-balloon
- Medical subject headings
- Peripheral Arterial Disease, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Femoropopliteal stenosis | Consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis/occlusion.
Intervention with Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon-PTA. Receives: Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically driven target lesion revascularization (TLR)
clinically driven target lesion revascularization
Measured: 6 months
Secondary outcomes (13)
clinically driven target vessel revascularization (TVR)
TVR
Measured: 6 months
Binary restenosis
Peak Systolic velocity (PSV) >2.4
Measured: 6 months
Change in Ankle Brachial Index (ABI)
Change in ankle brachial index from baseline.
Measured: 6 months
Change in Rutherford-classification
Change in Rutherford-Classification from Baseline (I-VI)
Measured: 6 months
major cardiac adverse events
myocardial infarction, stroke, death, cardiovascular death
Measured: 6 months
Amputation
Measured: 6 months
clinically driven target vessel revascularization (TVR)
Measured: 12 months
Clinically driven target lesion revascularization (TLR)
Measured: 12 months
Binary restenosis
Measured: 12 months
Change in Ankle Brachial Index (ABI)
Measured: 12 months
Change in Rutherford-classification
Measured: 12 months
major cardiac adverse events
myocardial infarction, stroke, death, cardiovascular death
Measured: 12 months
Amputation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Caritasklinik St. Theresia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Baumhäkel, Caritasklinik St. Theresia
- Investigators
- Magnus Baumhäkel, MD, Principal investigator, CaritasKlinikum, St. Theresia Saarbrücken, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198105
- Sponsor's protocol ID
- DEBTRAK-Registry
- Acronym
- DEBTRAK
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2014
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
- ClinicalTrials.gov ID
- NCT02198105
- Acronym / sponsor ID
- DEBTRAK / DEBTRAK-Registry
- Conditions
- Peripheral Artery Disease, Femoropoliteal Stenosis/Occlusion, Cutting-balloon, Drug-coated-balloon
- Keywords
- PAD, femoropoliteal stenosis/occlusion, cutting-balloon, drug-coated-balloon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Caritasklinik St. TheresiaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- PTA with Cutting-Balloon (60-120 seconds).
- PTA with Drug-Coated-Balloon (60 seconds).
Technical success is defined as
- no recoil >30%
- no dissection >Type B
- 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
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoropopliteal stenosis | – | Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTAConsecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis/occlusion. Intervention with Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon-PTA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion.
Key inclusion criteria (3 listed)
- peripheral artery disease (PAD) with femoro-popliteal stenosis >70% or occlusion (vessel diameter 4-6mm)
- age 18-99
- informed consent
Key exclusion criteria (2 listed)
- proximal / iliacal stenosis
- stenosis/occlusion of all arteries below the knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTAInterventional procedure: 1. PTA with Cutting-Balloon (60-120 seconds). 2. PTA with DC-Balloon (60 seconds). Technical success is defined as 1. no recoil >30% 2. no dissection >Type B 3. no stenting >30% of lesion length. | Device | Femoropopliteal stenosis |
Primary outcome
Clinically driven target lesion revascularization (TLR)
Time frame: 6 months
clinically driven target lesion revascularization
13 secondary outcomes
clinically driven target vessel revascularization (TVR)
Time frame: 6 months
Binary restenosis
Time frame: 6 months
Change in Ankle Brachial Index (ABI)
Time frame: 6 months
Change in Rutherford-classification
Time frame: 6 months
major cardiac adverse events
Time frame: 6 months
Amputation
Time frame: 6 months
clinically driven target vessel revascularization (TVR)
Time frame: 12 months
Clinically driven target lesion revascularization (TLR)
Time frame: 12 months
Binary restenosis
Time frame: 12 months
Change in Ankle Brachial Index (ABI)
Time frame: 12 months
Change in Rutherford-classification
Time frame: 12 months
major cardiac adverse events
Time frame: 12 months
Amputation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Baumhäkel, MD principal investigator
CaritasKlinikum, St. Theresia Saarbrücken, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease and Femoropoliteal Stenosis/Occlusion, run by Caritasklinik St. Theresia at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically driven target lesion revascularization (TLR) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.