Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions (PESTO-AFC)

Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions A Prospective, Multi-centre, Randomised Study

The endovascular therapy prevailed in nearly all regions of peripheral artery disease over open surgery techniques. However, in treatment of the common femoral artery vascular surgery is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Today, only in selected cases an endovascular procedure for common femoral artery diseases is recommended.

The primary objective of this study is to compare the performance of directional atherectomy and drug-coated balloon angioplasty over vascular surgery in common femoral artery lesions in a prospective, multi-center, randomized clinical trial.

Study Overview

• Status: Unknown
• Conditions: Peripheral Artery Disease; Artery Stenosis
• Intervention / Treatment: Device: Atherectomy and paclitaxel-coated balloon angioplasty; Procedure: Open, surgical endarterectomy

Detailed Description

Multicenter, prospective, randomized study to be conducted in centers in Europe. A total of 260 subjects will be entered into the study and will be randomized on a 1:1 basis to either directional atherectomy and drug coated balloon angioplasty (optional with stentimplantation), and surgical endarterectomy for treatment in symptomatic (Rutherford-Becker class 2 to 4) common femoral artery disease. All subjects will undergo repeat duplex-ultrasound measurements 6, 12, and 24 months to assess the primary endpoint of Binary Restenosis. Follow-up visits are scheduled 6, 12, and 24 months.

• Study Type: Interventional
• Enrollment (Anticipated): 306
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aljoscha Rastan, MD; Phone Number: 004976334024913; Email: aljoscha.rastan@universitaets-herzzentrum.de
• Study Contact Backup: Name: Thomas Zeller, MD; Phone Number: 004976332435; Email: thomas.zeller@universitaets-herzzentrum.de

Study Locations

• Germany
  • Bad Krozingen, Germany, 79219
    • Recruiting
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Contact: Aljoscha Rastan; Phone Number: 004976334024913; Email: aljosch.rastan@universitaets-herzzentrum.de
    • Contact: Thomas Zeller; Phone Number: 004976334022431; Email: thomas.zeller@universitaets-herzzentrum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject must be between 21 and 85 years old;
2. Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation;
3. Clinical diagnosis of symptomatic peripheral artery disease defined by Rutherford 2, 3, or 4;
4. Common femoral artery (CFA) stenosis (including CFA bifurcation) >70% (visual estimate) or occlusion; Additional non-target lesion(s) in remaining non-target vessel(s), except ipsilateral iliac arteries, can be treated at the physician´s discretion;
5. At least one vessel outflow (infrapopliteal arteries) to the foot (without stenosis >50%).
6. Endovascular Procedure: successful target lesion crossing of the guidewire (guidewire located intraluminally);
7. Non-target lesion interventions (TASC A and B) to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion and successful;
8. Willing to comply with the specified follow-up evaluation;
9. Written informed consent prior to any study procedures.

Exclusion Criteria:

1. Ipsilateral significant (>50%) stenosis of the iliac arteries.
2. Significant (>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot.
3. Angiographic evidence of thrombus within target vessel;
4. Thrombolysis within 72 hours prior to the index procedure;
5. In-Stent restenosis or restenosis of the native common femoral artery.
6. Aneurysm in the abdominal aorta or iliac arteries;
7. Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;
8. Recent MI or stroke < 30 days prior to the index procedure;
9. Life expectancy less than 24 months;
10. Known or suspected active infection at the time of the index procedure;
11. Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent;
12. Any significant medical condition which, in the investigator´s opinion, may interfere with the subject´s optimal participation in the study;
13. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endovascular procedure; Common femoral artery (target lesion) to be treated with directional atherectomy and paclitaxel-coated balloon angioplasty. Optional: stentimplantation.	Device: Atherectomy and paclitaxel-coated balloon angioplasty; Directional atherectomy and paclitaxel-coated balloon angioplasty (optional with stentimplantation) of the common femoral artery
Active Comparator: Surgery; Common femoral artery (target lesion) to be treated with open, surgical endarterectomy	Procedure: Open, surgical endarterectomy; open, surgical endarterectomy of the common femoral artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency	Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio >2.4.	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency	Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio >2.4.	24 month
target lesion revascularisation	Need for target lesion revascularisation after index procedure	6, 12, and 24 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rutherford-Becker class	Change in Rutherford-Becker class	6, 12, and 24 months

Collaborators and Investigators

• Sponsor: Herz-Zentrums Bad Krozingen
• Collaborators: Medtronic
• Investigators: Principal Investigator: Aljoscha Rastan, MD, aljoscha.rastan@universitaets-herzzentrum.de

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: drug-coated balloon; common femoral artery; surgical endarterectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: UHZ_RASA_PESTO_1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No