Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions

NCT01763476 | Completed DMC

• 1 other identifier: ADCAT(2)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number of these patients could be helped through medication or surgery. In fact within the first year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90% have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases 3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year primary patency rates up to 30%. The primary objective of this study is to compare the performance of atherectomy followed by a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo infrapopliteal lesions in a prospective, single-center, randomized clinical trial.

Conditions

Peripheral Artery Disease; Occlusion of Artery

Keywords

long infrapopliteal artery lesions; drug-coated balloon angioplasty; atherectomy

Outcome Measures

Primary Outcomes (1)

• primary patency

  Primary patency of the target lesion 6 months after index procedure measured by duplex ultrasound (PVR\>2.4) and angiography (core lab analysis).

  6 months

Secondary Outcomes (1)

• target lesion revascularisation (TLR)

  6 and 12 months

Other Outcomes (1)

• Change in Rutherford-Becker Class

  6 and 12 months

Study Arms (2)

Paclitaxel-coated balloon angioplasty

ACTIVE COMPARATOR

Target lesion to be treated with paclitaxel-coated balloon

Procedure: paclitaxel-coated balloon angioplasty

Atherectomy + paclitaxel-balloon

ACTIVE COMPARATOR

Target lesion to be treated with atherectomy (TurboHawk, ev3) and paclitaxel-coated balloon

Procedure: paclitaxel-coated balloon angioplasty; Procedure: atherectomy

Interventions

paclitaxel-coated balloon angioplasty PROCEDURE

plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion

Atherectomy + paclitaxel-balloon; Paclitaxel-coated balloon angioplasty

atherectomy PROCEDURE

atherectomy (TurboHawk, ev3) followed by paclitaxel-coated balloon angioplasty of the target lesion

Atherectomy + paclitaxel-balloon

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be between 50 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 critical limb ischemia as defined by Rutherford 3, 4, or 5
• Single treatment of de-novo lesion(s) in the tibioperoneal trunk, anterior and/or posterior tibial and/or peroneal artery with a lesion length ≥6cm;
• One vessel in 1 limb may be treated in the study. Additional non-target lesion(s) in remaining non-target vessel(s) can be treated at the physician´s discretion by means of balloon dilation or stent placement
• The total length of target lesion(s) can be maximum 250 mm
• In total a maximum of 4 drug-coated balloons may be used to fully cover the target lesion
• Target vessel is 2.0 and 3.5 mm in diameter (visual estimate)
• Target lesion stenosis is \>70% diameter stenosis (visual estimate)
• Guidewire must be across the target lesion and located intraluminally within the distal outflow vessel before study randomization
• Interventions in TASC A and B lesions to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion(s) and successful
• Willing to comply with the specified follow-up evaluation
• Written informed consent prior to any study procedures.

You may not qualify if:

• Significant (\>50%) stenoses distal to the target lesion (dorsalis pedis artery, plantar arch) that might require revascularization, or impede runoff;
• Angiographic evidence of thrombus within target vessel
• Thrombolysis within 72 hours prior to the index procedure
• In-Stent restenosis or restenosis of a native artery
• Aneurysm in the femoral artery or popliteal artery
• Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
• Recent myocardial infarction or stroke \< 30 days prior to the index procedure
• Life expectancy less than 12 months
• Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
• 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
• Medical University of Graz: collaborator

Study Sites (1)

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Related Publications (1)

• Rastan A, Brodmann M, Bohme T, Macharzina R, Noory E, Beschorner U, Flugel PC, Burgelin K, Neumann FJ, Zeller T. Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2021 Jun;14(6):e010280. doi: 10.1161/CIRCINTERVENTIONS.120.010280. Epub 2021 Jun 7.

  PMID: 34092093 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Arterial Occlusive Diseases

Interventions

Atherectomy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; 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

• Franz-Josef Neumann, M.D.

  Universitaets-Herzzentrum Freiburg-Bad Krozingen

  STUDY DIRECTOR

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: M.D.

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 9, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

DE (1)