Prospective, Multicenter, Post-market, Single Arm study to confirmthe performance of the RenzanTM Peripheral Stent System in treating Superficial Femoral and/or Popliteal artery disease

• Conditions: narrowed leg arteries; peripheral disease; 10003216

• Registration Number: NL-OMON51143
• Lead Sponsor: Terumo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

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 assessment).
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 childbearing 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety: Freedom from Death, Target Lesion Revascularization (TLR), or Any<br /><br>Amputation of the Index Limb up to 30 days.<br /><br>Efficacy: Patency at 12 Months </p><br>