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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03547986




Registration number
NCT03547986
Ethics application status
Date submitted
18/05/2018
Date registered
6/06/2018

Titles & IDs
Public title
BIO REsponse Adapted Combination Therapy Pilot Study
Scientific title
Evaluation of Adjunctive Procedural Assessments to Diagnose Post Drug-coated Balloon Flow-limiting Dissection and Residual Stenosis When Angiography is Inconclusive
Secondary ID [1] 0 0
C1706
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Duplex Ultrasound (DUS)
Diagnosis / Prognosis - IVUS with Intraarterial pressure measurement (IAP) if needed

Experimental: Duplex Ultrasound (DUS) - Standard angiography and DUS are performed on the same patients (paired data)

Experimental: IVUS with Intraarterial pressure measurement (IAP) - Standard angiography and Intra-Vascular Ultrasound (IVUS) with Intraarterial pressure measurement (IAP) are performed on the same patients (paired data)


Diagnosis / Prognosis: Duplex Ultrasound (DUS)
Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Duplex Ultrasound

Diagnosis / Prognosis: IVUS with Intraarterial pressure measurement (IAP) if needed
Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Intra-vascular ultrasound associated to Intraarterial pressure measurement if needed
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
diagnostic accuracy of duplex ultrasound
Timepoint [1] 0 0
during index procedure
Secondary outcome [1] 0 0
diagnostic accuracy of intraarterial pressure measurement
Timepoint [1] 0 0
during index procedure
Secondary outcome [2] 0 0
diagnostic accuracy of intraarterial pressure measurement with IVUS
Timepoint [2] 0 0
during index procedure
Secondary outcome [3] 0 0
Target lesion stenting rate
Timepoint [3] 0 0
during index procedure
Secondary outcome [4] 0 0
Number of stents used per target lesion
Timepoint [4] 0 0
during index procedure
Secondary outcome [5] 0 0
Average stent length per target lesion
Timepoint [5] 0 0
during index procedure
Secondary outcome [6] 0 0
Average target lesion length stented (full, spot)
Timepoint [6] 0 0
during index procedure
Secondary outcome [7] 0 0
DCB technical success
Timepoint [7] 0 0
during index procedure
Secondary outcome [8] 0 0
Stent technical success
Timepoint [8] 0 0
during index procedure
Secondary outcome [9] 0 0
Procedural success
Timepoint [9] 0 0
during index procedure
Secondary outcome [10] 0 0
Primary Patency
Timepoint [10] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [11] 0 0
Major Adverse Event (MAE)
Timepoint [11] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [12] 0 0
Major Adverse Cardiac Event (MACE)
Timepoint [12] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [13] 0 0
Major Adverse Limb Event (MALE)
Timepoint [13] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [14] 0 0
Clinically driven Target Lesion Revascularization
Timepoint [14] 0 0
1, 6, 12, 24 and 36 months post index procedure
Secondary outcome [15] 0 0
Major target limb amputation rate
Timepoint [15] 0 0
1, 6, 12, 24 and 36 months post index procedure
Secondary outcome [16] 0 0
all cause of death rate
Timepoint [16] 0 0
1, 6, 12, 24 and 36 months post index procedure
Secondary outcome [17] 0 0
Hemodynamic improvement
Timepoint [17] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [18] 0 0
Rate of primary sustained clinical improvement
Timepoint [18] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [19] 0 0
Rate of secondary sustained clinical improvement
Timepoint [19] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [20] 0 0
Health Related Quality of Life
Timepoint [20] 0 0
baseline, 1, 6 and 12 months post index procedure
Secondary outcome [21] 0 0
Walk Impairment
Timepoint [21] 0 0
baseline, 1, 6 and 12 months post index procedure
Secondary outcome [22] 0 0
Resource utilisation
Timepoint [22] 0 0
during index procedure, 12 month

Eligibility
Key inclusion criteria
* Subject has provided written informed consent before any study specific test or procedure and is willing and able to comply with the required follow-up visits and procedures
* Subject has a chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 to 4

Angiographic criteria:

* Single lesion or consecutive single lesions with a healthy segment(s) of = 2cm in-between
* De novo, restenotic or (re)occluded lesion(s) post Percutaneous Transluminal Angioplasty in the native superficial femoral artery (SFA) and or the proximal popliteal artery (PPA)
* Lesion(s) must be located at least 1 cm distal to the profunda femoris artery and at least 3 cm above the knee joint (radiographic joint space)
* Degree of stenosis =70% by visual angiographic assessment
* Vessel diameter = 4 and = 7 mm
* Patent inflow artery, free from significant lesion (>50%) as confirmed by angiography. Treatment of the target lesion is acceptable after successful treatment of inflow iliac and/or common femoral artery lesion. The inflow lesion cannot be treated with a DCB or a Drug Eluting Stent
* Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of the three vessels patent (<50% stenosis) to the ankle or foot with no planned intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previously stented target lesion
* Target lesion/ previously treated with drug-coated balloon <12 months prior to enrollment.
* Use of atherectomy, laser or other debulking devices in the target SFA/PPA vessel during the index procedure.
* Failure to cross the target lesion with the guide wire
* Presence of a complication following pre-dilation of target lesion, which in the opinion of the investigator would not allow the procedure to be performed in accordance with the REACT approach
* Presence of aneurysm in the target vessel.
* Prior on planned major amputation (above the ankle) in the target limb
* Acute ischemia and/or acute thrombosis of the target SFA/PPA vessel prior to enrollment.
* Perforation of the target vessel as evidenced by extravasation of contrast media prior to enrollment
* Known hypersensitivity or contraindication to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated
* Known hypersensitivity/allergy to Paclitaxel or other components of the investigational devices and comparator (e.g., nitinol, amorphous silicon carbide, polymer)
* Known hypersensitivity or contraindication to antiplatelet, anticoagulant, thrombolytic medications that would be administered during the study
* Subject with uncorrected bleeding disorders
* Subject with renal failure
* Life expectancy less than 12 months due to other comorbidities, that in the investigators opinion, could limit subject ability to comply with the study required follow-up visits/procedure and threaten the study scientific integrity
* Pregnant, breast feeding, or plan to become pregnant in the next 12 months.
* Current participation in another investigational drug or device clinical study that has not completed the primary endpoint at the time of enrollment or that upon investigator judgment could clinically interferes with the current study endpoints

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Aalst
Country [4] 0 0
Belgium
State/province [4] 0 0
Dendermonde
Country [5] 0 0
Belgium
State/province [5] 0 0
Kortrijk
Country [6] 0 0
France
State/province [6] 0 0
Nantes
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Germany
State/province [8] 0 0
Arnsberg
Country [9] 0 0
Germany
State/province [9] 0 0
Bad Krozingen
Country [10] 0 0
Germany
State/province [10] 0 0
Biederbach Baden-Wurttemberg
Country [11] 0 0
Germany
State/province [11] 0 0
Leipzig
Country [12] 0 0
Germany
State/province [12] 0 0
Tübingen
Country [13] 0 0
Germany
State/province [13] 0 0
Weinheim
Country [14] 0 0
Spain
State/province [14] 0 0
Guadalajara

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Koen Deloose, MD
Address 0 0
Sint Blasius Hospital Dendermonde, Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03547986