Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions

NCT02517827 | Unknown DMC

• 1 other identifier: UHZ_RASA_PESTO_1.0
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Artery Disease; Artery Stenosis

Keywords

common femoral artery; drug-coated balloon; surgical endarterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Primary patency

  24 month

• target lesion revascularisation

  6, 12, and 24 month

Other Outcomes (1)

• Rutherford-Becker class

  6, 12, and 24 months

Study Arms (2)

Endovascular procedure

ACTIVE COMPARATOR

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

Surgery

ACTIVE COMPARATOR

Common femoral artery (target lesion) to be treated with open, surgical endarterectomy

Procedure: Open, surgical endarterectomy

Interventions

Atherectomy and paclitaxel-coated balloon angioplasty DEVICE

Directional atherectomy and paclitaxel-coated balloon angioplasty (optional with stentimplantation) of the common femoral artery

Endovascular procedure

Open, surgical endarterectomy PROCEDURE

open, surgical endarterectomy of the common femoral artery

Surgery

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be between 21 and 85 years old;
• 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;
• Clinical diagnosis of symptomatic peripheral artery disease defined by Rutherford 2, 3, or 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;
• At least one vessel outflow (infrapopliteal arteries) to the foot (without stenosis \>50%).
• Endovascular Procedure: successful target lesion crossing of the guidewire (guidewire located intraluminally);
• 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;
• Willing to comply with the specified follow-up evaluation;
• Written informed consent prior to any study procedures.

You may not qualify if:

• Ipsilateral significant (\>50%) stenosis of the iliac arteries.
• Significant (\>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot.
• Angiographic evidence of thrombus within target vessel;
• Thrombolysis within 72 hours prior to the index procedure;
• In-Stent restenosis or restenosis of the native common femoral artery.
• Aneurysm in the abdominal aorta or iliac arteries;
• Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;
• Recent MI or stroke \< 30 days prior to the index procedure;
• Life expectancy less than 24 months;
• Known or suspected active infection at the time of the index procedure;
• Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent;
• Any significant medical condition which, in the investigator´s opinion, may interfere with the subject´s optimal participation in the study;
• 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.

Sponsors & Collaborators

• Herz-Zentrums Bad Krozingen: lead
• Medtronic: collaborator

Study Sites (1)

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, 79219, Germany

RECRUITING

Related Publications (1)

• Rastan A, Bohme T, Zeller T. Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial. Trials. 2024 Jun 8;25(1):370. doi: 10.1186/s13063-024-08219-1.

  PMID: 38851710 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Atherectomy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Aljoscha Rastan, MD

  aljoscha.rastan@universitaets-herzzentrum.de

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aljoscha Rastan, MD

CONTACT

004976334024913; aljoscha.rastan@universitaets-herzzentrum.de

Thomas Zeller, MD

CONTACT

004976332435; thomas.zeller@universitaets-herzzentrum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Executive senior physician

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 7, 2015
• Study Start: August 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

DE (1)