Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease

NCT04546477 | Active Not Recruiting DMC

• 1 other identifier: T134E5
• Study Type: interventional
• Target: 135
• Locations: 5 countries
• Sites: 13

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.

Conditions

Superficial Femoral Artery Disease; Popliteal Artery Disease

Keywords

Femoropopliteal; Peripheral intervention; Peripheral stent system

Outcome Measures

Primary Outcomes (4)

• Primary safety endpoint - Death

  Freedom from death.

  30 days

• Primary efficacy endpoint - TLR

  Freedom from Target Lesion Revascularization (TLR).

  30 days

• Primary efficacy endpoint - Amputation

  Freedom from any amputation of the index limb.

  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)

  12 months

Secondary Outcomes (16)

• Device Success

  Intraoperative

• Technical Success

  Intraoperative

• Procedural Success

  Intraoperative

• Any death

  at 1, 6, 12, 24, 36 months

• Ankle-brachial Index (ABI) on target limb

  at baseline, 1, 6, 12, 24 and 36 months

Study Arms (1)

Single Arm

OTHER

135 patients stratified into 2 groups: * FEM-POP patients: SFA-P1 * Isolated POP Patients: P1, P2, P3 only It is expected the majority of enrolled patients to be FEM-POP category. In case sufficient Isolated POP patients are enrolled, a sub-analysis will be performed on this group of patients.

Device: Stent implantation

Interventions

Stent implantation DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Subject must provide written informed consent prior to the treatment of the target lesion.
• Subject must be willing to comply with the specified follow-up evaluation schedule.
• Subject with Rutherford-Becker clinical classification category 2 to 5, with a resting ankle-brachial index (ABI) ≤ 0.9.
• A superficial femoral and/or popliteal artery lesion with \> 50% stenosis or total occlusion.
• 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.
• 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.
• 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).
• 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.
• 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.
• The subject is eligible for surgical repair, if necessary.

You may not qualify if:

• Subject has Rutherford-Becker classification category 6.
• Treatment of lesions requiring the use of adjunctive debulking devices.
• The use of drug-coated balloons at any step of the procedure.
• Required stent placement via a popliteal approach.
• Required stent placement across or within 0.5 cm of the superficial and profunda femoral artery bifurcation.
• In-stent restenosis treatment or any other procedure which requires stent-in-stent placement to obtain patency.
• Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
• Lesion with the length that would require stent overlap.
• Required stent placement within 1 cm of a previously deployed stent.
• Any significant vessel tortuosity or other parameters prohibiting access to the lesion and/or preventing the stent delivery.
• Subject with coronary intervention performed less than 90 days prior to or planned within 30 days after the treatment of the target lesion.
• Known allergies or intolerance to nitinol (nickel titanium), or contrast agent.
• Any contraindication or known unresponsiveness to dual antiplatelet therapy (DAPT) or anticoagulation therapy.
• Presence of acute thrombus prior to crossing the lesion.
• Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (13)

AZ Sint-Blasius

Dendermonde, Oost-Vlaanderen, 9200, Belgium

Location

Onze Lieve Vrouw (OLV) Ziekenhuis

Aalst, 9300, Belgium

Location

Imelda ziekenhuis

Bonheiden, 2820, Belgium

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Clinique Rhône-Durance

Avignon, 84000, France

Location

Hôpital Paris Saint-Joseph

Paris, 75014, France

Location

Clinique Saint Jean - Sud de France

Saint-Jean-de-Védas, 34433, France

Location

Klinikum Hochsauerland Karolinen-Hospital Hüsten

Arnsberg, 59759, Germany

Location

CCB MVZ Frankfurt und Main-Taunus GbR

Frankfurt, 60389, Germany

Location

Elblandklinikum Radebeul

Radebeul, Germany

Location

Diakonessenhuis

Utrecht, 3582, Netherlands

Location

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Universitario Cruces

Bilbao, 48903, Spain

Location

Study Officials

• Koen Deloose, Dr

  AZ Sint-Blasius Dendermonde

  PRINCIPAL INVESTIGATOR

• Torsten Fuss, Dr

  Elblandhospital Radebeul

  PRINCIPAL INVESTIGATOR

• Michael Lichtenberg, Dr

  Karolinen-Hospital: Klinikum Arnsberg

  PRINCIPAL INVESTIGATOR

• Jérôme Brunet, Dr.

  Clinique Rhône-Durance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: September 14, 2020
• Study Start: July 30, 2020
• Primary Completion: June 24, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); ES (2); DE (3); BE (4); FR (3)