Clinical Trial Investigating the Combination Therapy With Luminor DCB and iVolution Stent in TASC C and D Femoropopliteal Lesions (TINTIN)
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|ClinicalTrials.gov Identifier: NCT03347383|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2017
Last Update Posted : September 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Combination therapy DCB + stent||Not Applicable|
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term safety and efficacy of the combination therapy with the Luminor DCB and the iVolution stent post CE-certification and according to the indications of the Instructions for use (IFU) with focus on the treatment of TASC C and D femoropopliteal atherosclerotic lesions.
Patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should also be geographically stable, willing and able to cooperate in this clinical study and remain available for long-term follow-up. A patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following tests and clinical data will be collected: informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of chronic limb ischemia (Rutherford category) and resting ankle-brachial index (ABI).
During the procedure, the vascular access can be achieved to the investigator's standard clinical practice. After successful lesion passage, diagnostic angiography of the lesion area and distal run-off is performed and angiographic measurements (vessel diameter, percentage stenosis and lesion length) are collected. All inflow-limiting lesion will be treated according to the investigators standard clinical practice before treatment of the target lesion. Pre-dilatation of the target lesion is mandatory with the Oceanus balloon. After pre-dilatation, a least one Luminor DCB will be inflated and at least 1 iVolution stent will be deployed at the target lesion. At the physician's discretion, post-dilatation can be performed. No other adjunctive therapies (atherectomy, laser) are allowed. The complete femoropopliteal vasculature should be treated in one single session, staged interventions are not allowed. All outflow-limiting lesions must be treated according to the hospital treatment standard.
The regular follow-ups are necessary to monitor the condition of the patient and the procedure. Patients will be invited for a follow-up visit at 1, 6, 12, 24, 36, 48 and 60 months after the index procedure. The 24, 36, 48 and 60 month follow-up can be conducted via a phone call. The following data will be collected during these follow-up visit: medication record, physical examination, rutherford categorization, ABI and color flow doppler ultrasound.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physician Initiated, Prospective, Non-randomized Belgian Multi-center Trial, Investigating the Safety and Efficacy of the Treatment With the LumINor DCB and The IvolutioN Stent of iVascular in TASC C and D Femoropopliteal Atherosclerotic Disease|
|Actual Study Start Date :||September 19, 2017|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||January 2024|
Experimental: Combination therapy DCB + stent
Patients treated with the Luminor DCB and the iVolution stent
Device: Combination therapy DCB + stent
Patients will be treated with the Luminor DCB and iVolution stent
- Freedom from clinically-driven TLR at 12 months [ Time Frame: 12 months ]TLR defined as a repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points.
- Primary patency rate [ Time Frame: 6 and 12 months post-procedure ]Absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.5) at the target lesion and without TLR within the time of the procedure and the given follow-up.
- Technical success [ Time Frame: Index procedure ]Ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%
- Freedom from clinically-driven TLR [ Time Frame: 6, 24, 36, 48 and 60 months post-procedure ]TLR defined as a repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points.
- Clinical success [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months post-procedure ]Improvement of Rutherford classification compared to the pre-procedure Rutherford classification
- Serious Adverse Events (SAEs) [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months post-procedure ]Defined according to the Internal Organization of Standardization (ISO) guidelines: ISO 14155:2011
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): NCT03347383
|Aalst, Belgium, 9300|
|Antwerpen, Belgium, 2060|
|Bonheiden, Belgium, 2820|
|Dendermonde, Belgium, 9200|
|R.Z. Heilig Hart|
|Tienen, Belgium, 3300|
|AZ Jan Portaels|
|Study Director:||Koen Deloose, M.D.||ID3 Medical|