The primary objective of this study is to confirm the safety and efficacy of the RenzanTM Peripheral Stent System when used for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease. This trial plans to include 135 patients in (up to) 10 locations around in Europe.
PRIZER Study is a prospective, multicenter, post-market, single arm study with plan to include approximately 135 patients eligible to be treated with RenzanTM Peripheral Stent System stratified in 2 groups: 90 FEM-POP patients (From superficial femoral Artery to the Proximal edge of patella) and 45 Isolated POP patients (From Hunter's canal to the Origin of anterior tibial artery). The sponsor will work in accordance with standard operating procedures (SOP) and the Monitoring Plan in order to ensure adherence to the CIP and applicable regulations at the investigational sites. The Monitoring Plan is built according to a risk-based monitoring approach and describes the level of source data verification to be performed by the monitors. Risk-based monitoring approach uses all available means to supervise the trial (central monitoring, remote monitoring and on-site monitoring), focusing in critical data points and issues ensuring that adequate monitoring (central, remote and on-site) at each site is completed to ensure protection of the rights and safety of the subjects and the quality and integrity of the data collected and submitted. The sponsor shall provide training and the necessary guidelines to assist each investigational site on the data collection in the eCRF. Each site is responsible to report the available data requested by the CIP. In order to ensure data quality and avoid missing information in the eCRF, edit checks are designed during database development. In addition, Sponsor's CRA and Data Management team will be responsible to review the data and raise queries accordingly into the eCRF. An audit trail logging all data entered and edited is available within the EDC system. All source documents are maintained in the hospital files ready for inspection by the Sponsor and regulatory authorities upon request. The Sponsor will inform the investigator of the time period for retaining these records as per applicable regulatory requirements.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Procedure can be conducted via either contralateral or antegrade approach. After a successful target lesion crossing, predilate the lesion using either plain old balloon angioplasty (POBA) or (if necessary) any available specialty balloon. The inflated diameter of the balloon should approximate the diameter of the vessel just distal to the lesion. Proper vessel preparation should achieve diameter of 1:1 to healthy vessel (with ≤20% residual stenosis, as per operator's assessment). Adjunctive debulking devices are prohibited. Final stent selection should be confirmed after a proper vessel preparation, considering the reference vessel diameter (RVD) for the optimal 1:1 stent-to-vessel sizing. The implanted dual layer length would encompass the entire lesion with the micromesh, covering it from healthy to healthy tissue. Post-dilatation of the stent for more optimal placement may be done at operator's discretion, using standard angioplasty with uncoated balloon.
AZ Sint-Blasius
Dendermonde, Oost-Vlaanderen, Belgium
Onze Lieve Vrouw (OLV) Ziekenhuis
Aalst, Belgium
Imelda ziekenhuis
Bonheiden, Belgium
Primary safety endpoint - Death
Freedom from death.
Time frame: 30 days
Primary efficacy endpoint - TLR
Freedom from Target Lesion Revascularization (TLR).
Time frame: 30 days
Primary efficacy endpoint - Amputation
Freedom from any amputation of the index limb.
Time frame: 30 days
Primary efficacy endpoint
Primary patency of the artery at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR) (excluding TLR due to thrombosis within 30 days)
Time frame: 12 months
Device Success
Defined as a successful device deployment according to IFU.
Time frame: Intraoperative
Technical Success
Defined as achievement of a final target lesion residual diameter stenosis of \<30% based on angiography.
Time frame: Intraoperative
Procedural Success
Defined as technical and device success without procedural complication.
Time frame: Intraoperative
Any death
Cardiovascular death and Non-cardiovascular death
Time frame: at 1, 6, 12, 24, 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ziekenhuis Oost Limburg
Genk, Belgium
Clinique Rhône-Durance
Avignon, France
Hôpital Paris Saint-Joseph
Paris, France
Clinique Saint Jean - Sud de France
Saint-Jean-de-Védas, France
Klinikum Hochsauerland Karolinen-Hospital Hüsten
Arnsberg, Germany
CCB MVZ Frankfurt und Main-Taunus GbR
Frankfurt, Germany
Elblandklinikum Radebeul
Radebeul, Germany
...and 3 more locations
Ankle-brachial Index (ABI) on target limb
Defined as a ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.
Time frame: at baseline, 1, 6, 12, 24 and 36 months
Clinically-driven Target Lesion Revascularization (CD-TLR)
Defined as any TLR associated with deterioration of patient's Rutherford category and/or increase in size of pre-existing ischemic wounds and/or occurrence of new wounds.
Time frame: at 1, 6, 12, 24 and 36 months
Target Lesion Revascularization (TLR)
Defined as any repeat percutaneous intervention or bypass surgery performed on the target lesion (including 5mm proximal and distal from the implanted stent).
Time frame: at 1, 6, 12, 24 and 36 months
Target Vessel Revascularization (TVR)
Defined as any repeat percutaneous intervention or bypass surgery performed on the target vessel.
Time frame: at 1, 6, 12, 24 and 36 months
Patency of the target lesion
Defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR) (excluding TLR due to thrombosis within 30 days). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity ratio (PSVR) of ≥ 2.4 when compared to the proximal normal segment, respectively.
Time frame: at 6, 24 and 36 months
Limb Ischemia Improvement
Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to 1.
Time frame: at 1, 6, 12, 24 and 36 months
Major Adverse Events (MAE)
Defined as a composite rate of: * cardiovascular death * procedure-related arterial rupture * acute limb ischemia * stent thrombosis * clinically apparent distal embolization * target limb amputation * procedure-related bleeding event requiring transfusion
Time frame: at 1, 6, 12, 24 and 36 months
Index Limb Amputations
Defined as the surgical removal of tissue anywhere from the toe to hip.
Time frame: at 1, 6, 12, 24 and 36 months
Quality of Life (QoL)
Quality of Life (QoL) assessed as per EQ-5D questionnaire
Time frame: at baseline, 1, 6, 12, 24 and 36 months
Walking performance
Walking performance assessed as per Walking Impairment Questionnaire (WIQ)
Time frame: at baseline, 1, 6, 12, 24 and 36 months
Rutherford-Becker Scale
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease, Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication, Category 4 = Ischemic rest pain, Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above trans metatarsal level, functional foot no longer salvageable.
Time frame: at baseline, 1, 6, 12, 24 and 36 months
Clinical Improvement
Clinical Improvement compared with baseline as per Rutherford-Becker Clinical Improvement Scale
Time frame: at 1, 6, 12, 24 and 36 months