Clinical trial NCT04546477: Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease
Official title: Prospective, Multicenter, Post-market, Single Arm Study to Confirm the Performance of the RenzanTM Peripheral Stent System in Treating Superficial Femoral and/or Popliteal Artery Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Superficial Femoral Artery Disease
Popliteal Artery Disease
Keywords: Femoropopliteal
Peripheral intervention
Peripheral stent system
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Peripheral Stent placement at the location of the initially stenosed or occluded femoropopliteal lesion after proper (1:1 to the reference vessel diameter) vessel preparation without the use of adjunctive debulking devices. Proper vessel preparation should result in ≤20% residual stenosis (as per operator's assessment).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Subject must provide written informed consent prior to the treatment of the target lesion.
3. Subject must be willing to comply with the specified follow-up evaluation schedule.
4. Subject with Rutherford-Becker clinical classification category 2 to 5, with a resting ankle-brachial index (ABI) ≤ 0.9.
5. A superficial femoral and/or popliteal artery lesion with \> 50% stenosis or total occlusion.
6. Stenotic or occluded lesion(s) within the same vessel (one long or multiple serial lesions treatable with one stent) ≥ 40 mm and ≤ 140 mm in length, with reference vessel diameter (RVD) ≥ 4.0 mm and ≤ 7.0 mm by visual assessment.
7. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of ipsilateral iliac lesions); Successful ipsilateral iliac artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication, either with PTA or stenting.
8. The target lesion(s) can be successfully crossed with a guide wire and dilated up to 1:1 to healthy vessel (as per operator's assesment).
9. At least one patent native outflow artery (anterior or posterior tibial or peroneal) to the foot, free from significant (≥50%) stenosis (as confirmed by angiography), that has not previously been revascularized. The remaining outflow arteries requiring treatment during the same procedure may be treated only with uncoated devices and before the target lesion.
10. A subject with bilateral obstructive SFA disease is eligible for enrollment into the study. If a subject with bilateral disease is enrolled, the target limb will be selected at the Investigator's discretion, who may use the criteria of lesion length, percent stenosis, and/or calcification content. The contra-lateral procedure should not be done until at least 30 days after the index procedure; however, if contralateral treatment is performed prior to treatment of the target lesion it should be performed at least 1 day before the index procedure with uncoated devices only.
11. The subject is eligible for surgical repair, if necessary.

Exclusion Criteria:

1. Subject has Rutherford-Becker classification category 6.
2. Treatment of lesions requiring the use of adjunctive debulking devices.
3. The use of drug-coated balloons at any step of the procedure.
4. Required stent placement via a popliteal approach.
5. Required stent placement across or within 0.5 cm of the superficial and profunda femoral artery bifurcation.
6. In-stent restenosis treatment or any other procedure which requires stent-in-stent placement to obtain patency.
7. Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
8. Lesion with the length that would require stent overlap.
9. Required stent placement within 1 cm of a previously deployed stent.
10. Any significant vessel tortuosity or other parameters prohibiting access to the lesion and/or preventing the stent delivery.
11. Subject with coronary intervention performed less than 90 days prior to or planned within 30 days after the treatment of the target lesion.
12. Known allergies or intolerance to nitinol (nickel titanium), or contrast agent.
13. Any contraindication or known unresponsiveness to dual antiplatelet therapy (DAPT) or anticoagulation therapy.
14. Presence of acute thrombus prior to crossing the lesion.
15. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
16. Thrombophlebitis or deep venous thrombus, within the previous 30 days.
17. Subject receiving dialysis within the previous 30 days.
18. Stroke within the previous 90 days.
19. Known or suspected active infection at the time of the procedure.
20. Subject is pregnant or of child bearing potential
21. Subject has life expectancy of less than 1 year.
22. Subject is participating in an investigational study that has not reached primary endpoint at the time of study screening.
23. Treatment of outflow arteries (anterior or posterior tibial or peroneal) following target lesion treatment (unless bailout).
24. In France: Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken ("protected majors" as per French law: articles L1121-5, 6, 8 et L1122-1-3, du code de la santé publique)

Primary outcomes:
measure: Primary safety endpoint - Death
timeFrame: 30 days
measure: Primary efficacy endpoint - TLR
timeFrame: 30 days
measure: Primary efficacy endpoint - Amputation
timeFrame: 30 days
measure: Primary efficacy endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Device Success
timeFrame: Intraoperative
measure: Technical Success
timeFrame: Intraoperative
measure: Procedural Success
timeFrame: Intraoperative
measure: Any death
timeFrame: at 1, 6, 12, 24, 36 months
measure: Ankle-brachial Index (ABI) on target limb
timeFrame: at baseline, 1, 6, 12, 24 and 36 months
measure: Clinically-driven Target Lesion Revascularization (CD-TLR)
timeFrame: at 1, 6, 12, 24 and 36 months
measure: Target Lesion Revascularization (TLR)
timeFrame: at 1, 6, 12, 24 and 36 months
measure: Target Vessel Revascularization (TVR)
timeFrame: at 1, 6, 12, 24 and 36 months
measure: Patency of the target lesion
timeFrame: at 6, 24 and 36 months
measure: Limb Ischemia Improvement
timeFrame: at 1, 6, 12, 24 and 36 months
measure: Major Adverse Events (MAE)
timeFrame: at 1, 6, 12, 24 and 36 months
measure: Index Limb Amputations
timeFrame: at 1, 6, 12, 24 and 36 months
measure: Quality of Life (QoL)
timeFrame: at baseline, 1, 6, 12, 24 and 36 months
measure: Walking performance
timeFrame: at baseline, 1, 6, 12, 24 and 36 months
measure: Rutherford-Becker Scale
timeFrame: at baseline, 1, 6, 12, 24 and 36 months
measure: Clinical Improvement
timeFrame: at 1, 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
state: Oost-Vlaanderen
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw (OLV) Ziekenhuis
city: Bonheiden
country: Belgium
facility: Imelda ziekenhuis
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Avignon
country: France
facility: Clinique Rhône-Durance
city: Paris
country: France
facility: Hôpital Paris Saint-Joseph
city: Saint-Jean-de-Védas
country: France
facility: Clinique Saint Jean - Sud de France
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland Karolinen-Hospital Hüsten
city: Frankfurt
country: Germany
facility: CCB MVZ Frankfurt und Main-Taunus GbR
city: Radebeul
country: Germany
facility: Elblandklinikum Radebeul
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Bilbao
country: Spain
facility: Hospital Universitario Cruces
Study officials:
affiliation: AZ Sint-Blasius Dendermonde
name: Koen Deloose, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Elblandhospital Radebeul
name: Torsten Fuss, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinen-Hospital: Klinikum Arnsberg
name: Michael Lichtenberg, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Rhône-Durance
name: Jérôme Brunet, Dr.
role: PRINCIPAL_INVESTIGATOR
References: