Clinical trial NCT05399680: Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access
Official title: Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
Collaborators: name: Qserve
name: NAMSA
First posted: 2022-06-01
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this clinical investigation is to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ Nitinol Stent, in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via radial artery access.

Detailed description: RADIANCY is an acute, multi-center, single-arm, non-randomized, prospective, pivotal (pre-market) clinical study, whose primary objective is to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ self-expanding stent in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via transradial artery access. The study enrolled 151 subjects, 22 of which were enrolled as "roll-in" subjects, across 12 investigational sites across Europe. These subjects will be followed up to 30 days post-procedure.

Eligibility criteria: Inclusion Criteria:

Subjects must meet ALL of the following inclusion criteria to be enrolled in the study:

ALL patients must meet the following criteria prior to enrollment:

1. Age ≥ 18 years
2. For women of child-bearing potential, a negative pregnancy test within seven (7) days prior to the index procedure
3. Symptomatic leg ischemia or ischemic ulcerations that do NOT exceed digits of the foot (Rutherford/Becker Classification category 2, 3, 4 or 5)
4. Palpable radial artery with diameter ≥ 2.5 mm, as assessed by duplex ultrasound
5. Eligibility for standard surgical repair, if necessary
6. A patient who requires a coronary intervention should have it performed at least seven (7) days prior to treatment of the target lesion
7. The patient must provide documented informed consent and any other documented authorization, as required, prior to initiation of the study procedure
8. Per Investigator assessment, the patient is willing and able to be followed up to 30 days post-procedure for evaluation and complete all required assessments per the study protocol.

   Inclusion criteria 9 and 10 AND 11a through 14a OR 11b through 16b (whichever is applicable) would be assessed via baseline angiography performed at the time of index procedure:
9. The Investigator has assessed that the patient is a suitable candidate (i.e, meets all inclusion criteria and none of the exclusion criteria), for treatment of a lesion in the iliac, superficial femoral and/or proximal popliteal arteries via transradial approach and is eligible for conversion from a transradial to transfemoral approach, if it becomes necessary.
10. The guidewire is across the target lesion(s) and located intraluminally within the distal vessel following a transradial approach

Patients whose target lesion is in the iliac artery must meet these additional criteria prior to enrollment:

11a. A single de novo or restenotic lesion ≥ 50% stenosis in the common and/or external iliac artery

12a. Stenotic lesion (one long or multiple serial/tandem lesions) less than or equal to 100 mm, by visual assessment, within or across the common or external iliac arteries. The stenosis must be treatable with no more than two stents (while minimizing stent overlap)

13a. Reference vessel diameter (RVD) ranging from 4.0 to 9.0 mm by visual assessment

14a. Angiographic evidence of a patent profunda or superficial femoral artery in the diseased (target) limb

Patients whose target lesion is in the SFA and/or PPA must meet these additional criteria prior to enrollment:

11b. A single de novo or restenotic lesion ≥ 50% stenosis in the SFA and/or PPA

12b. Stenotic lesion (one long or multiple serial/tandem lesions) less than or equal to 150 mm, by visual assessment, within or across the SFA and/or PPA. The stenosis must be treatable with no more than two stents (while minimizing stent overlap)

13b. RVD ranging from 4.0 to 7.0 mm by visual assessment

14b. All lesions are to be located at least three centimeters proximal to the superior edge of the patella

15b. Patent infrapopliteal artery, i.e., single vessel runoff or better with patency (\<50% stenosis) of at least one of three vessels to the ankle or foot

16b. Adequate aortoiliac or common femoral "inflow" (defined as \< 30% stenosis after PTA or stenting) prior to treatment of the target lesion (defined as \< 30% stenosis after PTA or stenting) prior to treatment of the target lesion

Exclusion Criteria:

Patients will be excluded if ANY of the following exclusion criteria apply:

1. The patient has had/experienced any prior intervention/treatment to the target vessel within 90 days prior to enrollment (e.g., previously implanted graft in the aorta or target vessel; stroke; cryoplasty, laser or atherectomy; abdominal aortic aneurysm or aneurysm of the iliac, superficial femoral or popliteal artery).
2. Previously deployed stent at the site of the target lesion
3. The patient has post-surgical stenosis and anastomotic suture treatments of the target vessel
4. Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the stenting procedure
5. Use of mechanical devices on or thrombolysis of the target vessel within 72 hours prior to the index procedure without complete resolution of the thrombus
6. The patient is receiving any form of dialysis.
7. The patient is receiving any form of immunosuppressant therapy.
8. Planned amputation
9. Established vasospastic disease
10. Glomerular filtration rate (GFR) \< 30 mL/min within 7 days prior to the index procedure
11. The patient has a history of neutropenia, coagulopathy, and/or thrombocytopenia.
12. Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days prior to the index procedure
13. Bleeding diathesis
14. Known allergies or intolerance to antiplatelet, anticoagulant or thrombolytic medications including but not limited to aspirin, clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®) or heparin that cannot be medically managed.
15. Known allergy or intolerance to Nitinol (nickel titanium)
16. Known allergy to contrast agent that cannot be medically managed before treatment with steroids and/or antihistamines.
17. Known or suspected active infection at the time of the index procedure.
18. Patient is currently participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or is planning to participate in such a study prior to their completion of this study.
19. Patient has had a major surgical or interventional procedure unrelated to this study within 30 days prior to enrollment or is anticipated/planned to have such a procedure within 30 days after enrollment.

    Exclusion criteria 20 through 25 would be assessed via baseline angiography performed at the time of index procedure:
20. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
21. Noted perforation of the target vessel
22. Stent placement required across or within 0.5 cm of the SFA/profunda femoris artery (PFA) bifurcation
23. Cases of chronic total occlusion/in-stent restenosis/severe calcification in which there is pre-determined inability to treat the target lesion with a single stent, or procedures pre-determined to require stent-in-stent placement to obtain patency
24. Presence of thrombus prior to crossing the lesion
25. Successful PTA treatment of a target lesion in the SFA/PPA (defined as \< 50% stenosis after PTA treatment)

Primary outcomes:
measure: Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome)
timeFrame: From start of index procedure (time of initial puncture in the radial access artery) to the first occurrence of access site complication, time of discharge (~ up to 1 week from date of index procedure) or study exit, whichever comes first
measure: Technical Success of Using the S.M.A.R.T. RADIANZ™ Vascular Stent System (Primary Efficacy Outcome)
timeFrame: From the time of insertion through the time of withdrawal of the SMART RADIANZ delivery system through the radial access artery, assessed within the same day or 24 hours from the start time of the index procedure.
Secondary outcomes:
measure: Device Deficiencies through 30 Days Post-Procedure
timeFrame: From the time of first use/handling of the device to 30 days from date of index procedure or study exit, whichever comes first
measure: Adverse Events through 30 Days Post-Procedure
timeFrame: From index procedure start (time of initial puncture in the radial access artery) to the first occurrence of adverse event, 30 days from date of index procedure or study exit, whichever comes first
measure: Death, Index Limb Amputation and TLR through 30 Days Post-Procedure
timeFrame: From index procedure start (time of initial puncture in the radial access artery) to the first occurrence of death, index limb amputation or TLR, 30 days from date of index procedure or study exit, whichever comes first
measure: Procedural Complications through 30 Days Post-Procedure
timeFrame: From index procedure start (time of initial puncture in the radial access artery) to the first occurrence of procedural complication, 30 days from date of index procedure or study exit, whichever comes first
measure: Technical Success of Using the BRITE TIP RADIANZ™ Guiding Sheath
timeFrame: From the time of insertion through the time of withdrawal of the BRITE TIP RADIANZ™ Guiding Sheath through the radial access artery, assessed within the same day or 24 hours from the start time of the index procedure.
measure: Procedural Success of Using the SABERX RADIANZ™ PTA Balloon Catheter
timeFrame: From the time of insertion through the time of withdrawal of the SABERX RADIANZ™ PTA Balloon Catheter through the radial access artery AND assessment of the final residual diameter stenosis, within the same day or 24 hours from the procedure start time
Other outcomes:
measure: Fluoroscopy Time and Procedural Time
timeFrame: From the time of introduction of the sheath through the radial access artery to the time of vascular closure, within the same day or 24 hours from the procedure start time
measure: Time to Achieve Hemostasis
timeFrame: From the time of removal of the vascular closure device to the time when hemostasis was first observed, within the same day or 24 hours from the procedure start time
measure: Time to Ambulation
timeFrame: From the time of vascular closure to the time of ambulation, within the same day or 24 hours from the procedure start time, or study exit, whichever comes first
measure: Time to Hospital Discharge
timeFrame: From the time of vascular closure to the time of hospital discharge (~ up to 1 week from date of index procedure) or study exit, whichever comes first
measure: Method to Achieve Closure of the Transradial Artery Access Site
timeFrame: From the time of withdrawal of the sheath and guidewire to time of removal of the vascular closure device, within the same day or 24 hours from the procedure start time
measure: Quality of Life Assessed via the SF-36 Questionnaires
timeFrame: From up to 7 days prior to the index procedure date through the 30-day follow-up visit (up to 37 days post-procedure) or study exit, whichever comes first
measure: Quality of Life Assessed via the EuroQOL-5 Dimensions (EQ-5D) Questionnaires
timeFrame: From up to 7 days prior to the index procedure date through the 30-day follow-up visit (up to 37 days post-procedure) or study exit, whichever comes first
measure: Time to hospital discharge eligibility
timeFrame: From the time of vascular closure to the time of hospital discharge eligibility (~ up to 1 week from date of index procedure) or study exit, whichever comes first
Locations:
city: Graz
country: Austria
facility: Univ Klinikum LKG Graz
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörtherse
city: Vienna
country: Austria
facility: Hanusch Krankenhaus
city: Vienna
country: Austria
facility: Univ.-Klinik für Innere Medizin II
city: Dendermonde
country: Belgium
facility: A.Z. Sint-Blasius Hospital-Dendermonde
city: Boulogne-Billancourt
country: France
facility: Hospital Ambroise Pare
city: Paris
country: France
facility: Groupe Hôpital Paris St Joseph
city: Strasbourg
country: France
facility: Clinique Rhena
city: Toulouse
country: France
facility: Clinique Pasteur
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Guadalajara
country: Spain
facility: Hosp Univ. de Guadalajara
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
References: