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

Peripheral Arterial Disease Clinical Trial

— RADIANCY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399680
• Other study ID #: P21-7701
• Status: Completed
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: November 13, 2023

Study information

• Verified date: November 2023
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 13, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• S.M.A.R.T. RADIANZ™ Vascular Stent System
The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
• BRITE TIP RADIANZ™ Guiding Sheath
BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
• SABERX RADIANZ™ PTA Balloon Catheter
SABERX RADIANZ™ is a catheter with a distal inflatable balloon.

Locations

Country	Name	City	State
Austria	Univ Klinikum LKG Graz	Graz
Austria	Klinikum Klagenfurt am Wörtherse	Klagenfurt
Austria	Hanusch Krankenhaus	Vienna
Austria	Univ.-Klinik für Innere Medizin II	Vienna
Belgium	A.Z. Sint-Blasius Hospital-Dendermonde	Dendermonde
France	Hospital Ambroise Pare	Boulogne-Billancourt
France	Groupe Hôpital Paris St Joseph	Paris
France	Clinique Rhena	Strasbourg
France	Clinique Pasteur	Toulouse
Italy	Maria Cecilia Hospital	Cotignola
Spain	Hosp Univ. de Guadalajara	Guadalajara
Switzerland	Kantonsspital Winterthur	Winterthur

Sponsors (3)

Lead Sponsor	Collaborator
Cordis Corporation	NAMSA, Qserve

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fluoroscopy Time and Procedural Time	Fluoroscopy time and procedural time, defined as the time of sheath introduction to time of vascular closure	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
Other	Time to Achieve Hemostasis	Time to achieve hemostasis defined as the time elapsed from removal of the BRITE TIP RADIANZTM Guiding Sheath to the time that hemostasis was first observed	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
Other	Time to Ambulation	Time to ambulation, defined as when the subject can stand up and walk any distance	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
Other	Time to Hospital Discharge	Time to hospital discharge	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
Other	Method to Achieve Closure of the Transradial Artery Access Site	Method to achieve closure of the transradial artery access site	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
Other	Quality of Life Assessed via the SF-36 Questionnaires	Quality of life assessed via the SF-36 questionnaires. Mean scores are reported on a scale entitled "mean score" and range from 0 (minimum) to 100 (maximum); higher scores represent a better outcome.	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
Other	Quality of Life Assessed via the EuroQOL-5 Dimensions (EQ-5D) Questionnaires	Quality of life assessment (health state utility and visual analog rating of health status) via administration of the EQ-5D questionnaires. Mean scores for utility rating are reported on a scale entitled "mean score" and range from 0 (minimum) to 1 (maximum) while mean scores for visual analog rating are reported on a scale entitled "mean score" and range from 0 (minimum) to 100 (maximum); higher scores represent a better outcome in both cases.	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
Other	Time to hospital discharge eligibility	Time to hospital discharge eligibility (when physician examines and if all is well, gives discharge orders)	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
Primary	Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome)	Occurrence rate of CEC-adjudicated, major radial access site complications attributed to study device or procedure-related complications (adverse events) associated with transradial artery access through time of hospital discharge.	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
Primary	Technical Success of Using the S.M.A.R.T. RADIANZ™ Vascular Stent System (Primary Efficacy Outcome)	Technical success at the conclusion of the index procedure, defined as successful insertion of the S.M.A.R.T. RADIANZ™ Vascular Stent System into the peripheral vasculature through the radial artery, successful deployment of the study device (S.M.A.R.T.TM stent) at the intended location, and successful withdrawal of the delivery system without conversion from radial to femoral artery access.	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	Device Deficiencies through 30 Days Post-Procedure	For each of the three (3) devices, peri-procedural (within 30 days post-index procedure) rate of device deficiencies	From the time of first use/handling of the device to 30 days from date of index procedure or study exit, whichever comes first
Secondary	Adverse Events through 30 Days Post-Procedure	Peri-procedural (within 30 days post-index procedure) rate of adverse events	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
Secondary	Death, Index Limb Amputation and TLR through 30 Days Post-Procedure	Peri-procedural (within 30 days post-index procedure) rate of death, index limb amputation and target lesion revascularization	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
Secondary	Procedural Complications through 30 Days Post-Procedure	Peri-procedural (within 30 days post-index procedure) rate of procedural complications	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
Secondary	Technical Success of Using the BRITE TIP RADIANZ™ Guiding Sheath	Technical success associated with use of the BRITE TIP RADIANZ™ Guiding Sheath, defined as successful insertion of the device into the peripheral vasculature through the radial artery (allowing for introduction of interventional and/or diagnostic devices) and successful withdrawal of the device.	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.
Secondary	Procedural Success of Using the SABERX RADIANZ™ PTA Balloon Catheter	Procedural success associated with use of the SABERX RADIANZ™ PTA Balloon Catheter for pre-dilation and/or post-deployment stent dilatation (whenever applicable), defined as successful insertion of the device into the peripheral vasculature through the radial artery, successful inflation and deflation of the balloon, successful withdrawal of the device, and achievement of a final residual diameter stenosis of < 30% at the conclusion of the index procedure.	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