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

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ClinicalTrials.gov Identifier: NCT02198105
Recruitment Status : Unknown
Verified July 2016 by Magnus Baumhäkel, Caritasklinik St. Theresia.
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2014
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Magnus Baumhäkel, Caritasklinik St. Theresia

Study Description
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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).

Condition or disease Intervention/treatment
Peripheral Artery Disease Femoropoliteal Stenosis/Occlusion Cutting-balloon Drug-coated-balloon Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon 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).

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
Study Start Date : May 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : November 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.

 Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA

Interventional 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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinically driven target lesion revascularization (TLR) [ Time Frame: 6 months ]
    clinically driven target lesion revascularization


Secondary Outcome Measures :
  1. clinically driven target vessel revascularization (TVR) [ Time Frame: 6 months ]
    TVR

  2. Binary restenosis [ Time Frame: 6 months ]
    Peak Systolic velocity (PSV) >2.4

  3. Change in Ankle Brachial Index (ABI) [ Time Frame: 6 months ]
    Change in ankle brachial index from baseline.

  4. Change in Rutherford-classification [ Time Frame: 6 months ]
    Change in Rutherford-Classification from Baseline (I-VI)

  5. major cardiac adverse events [ Time Frame: 6 months ]
    myocardial infarction, stroke, death, cardiovascular death

  6. Amputation [ Time Frame: 6 months ]
  7. clinically driven target vessel revascularization (TVR) [ Time Frame: 12 months ]
  8. Clinically driven target lesion revascularization (TLR) [ Time Frame: 12 months ]
  9. Binary restenosis [ Time Frame: 12 months ]
  10. Change in Ankle Brachial Index (ABI) [ Time Frame: 12 months ]
  11. Change in Rutherford-classification [ Time Frame: 12 months ]
  12. major cardiac adverse events [ Time Frame: 12 months ]
    myocardial infarction, stroke, death, cardiovascular death

  13. Amputation [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198105


Locations
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Germany
CaritasKlinikum, St. Theresia
Saarbrücken, Saarland, Germany, 66113
Sponsors and Collaborators
Caritasklinik St. Theresia
Investigators
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Principal Investigator: Magnus Baumhäkel, MD CaritasKlinikum, St. Theresia Saarbrücken, Germany
More Information
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Additional Information:

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Responsible Party: Magnus Baumhäkel, PD Dr. med. Magnus Baumhäkel, Caritasklinik St. Theresia
ClinicalTrials.gov Identifier: NCT02198105    
Other Study ID Numbers: DEBTRAK-Registry
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Keywords provided by Magnus Baumhäkel, Caritasklinik St. Theresia:
PAD
femoropoliteal stenosis/occlusion
cutting-balloon
drug-coated-balloon
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Constriction, Pathologic
Pathological Conditions, Anatomical
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases