Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries

NCT02013193 | Completed DMC

• 2 other identifiers: HTQ001-RangerSFACIV-13-07-011514
• Study Type: interventional
• Target: 105
• Locations: 3 countries
• Sites: 11

Brief Summary

The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.

Conditions

Peripheral Artery Disease; Claudication; Atherosclerosis; Arteriosclerosis

Keywords

drug-coated balloon; drug-eluting balloon; peripheral artery disease; claudication

Outcome Measures

Primary Outcomes (1)

• in-segment late lumen loss

  In-segment late lumen loss (LLL) of the treated segment after PTA using the Ranger™ paclitaxel-coated PTA balloon, in comparison to the LLL after PTA using an uncoated balloon, as observed by angiography at six months post-index procedure.

  six months

Secondary Outcomes (20)

• technical success

  during index procedure, less 1 hour

• procedural success

  within 24 hours of index procedure

• primary patency

  six months

• primary patency

  twelve months

• assisted primary patency

  six months

Study Arms (2)

Ranger(TM) Paclitaxel-coated balloon

EXPERIMENTAL

Index lesion treated with Ranger(TM) Paclitaxel-coated PTA balloon catheter (Ranger DCB)

Device: Ranger DCB

uncoated PTA balloon

ACTIVE COMPARATOR

Index lesion treated with an uncoated standard PTA dilatation balloon catheter selected upon investigator´s discretion

Device: uncoated PTA balloon

Interventions

Ranger DCB DEVICE

After successful pre-dilatation the index lesion is treated with one or two Ranger DCB devices that completely cover the lesion. If two devices are deployed, overlap shall be minimal.

Ranger(TM) Paclitaxel-coated balloon

uncoated PTA balloon DEVICE

The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.

uncoated PTA balloon

Eligibility Criteria

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

You may qualify if:

• Subjects must be age 18 or older
• Subject is willing and able to provide informed consent
• Subject is available to attend all required follow-up visits
• Subject has a clinically significant symptomatic leg ischemia requiring treatment
• Subject has a Rutherford clinical category of 2-4
• If the index lesion is restenotic, the prior PTA must have been \>30 days prior to treatment in the current study
• Only one lesion per limb can be treated under this protocol.
• Successful intraluminal wire crossing of the target lesion
• Index lesion is a clinically and hemodynamically significant stenotic or restenotic lesion located in the native nonstented superficial femoral artery or proximal popliteal artery
• Degree of stenosis 70% or more, by visual assessment
• Lesion length between 20 mm and 150 mm
• At least one patent infrapopliteal artery to the foot of the index limb

You may not qualify if:

• Subjects who have undergone prior vascular surgery of the femoropopliteal artery in the index limb to treat atherosclerotic disease
• History of major amputation in the same limb as the target lesion
• Presence of aneurysm in the target vessel
• Acute ischemia and/or acute thrombosis in any artery of the lower limbs
• Acute Myocardial Infarction within 30 days before the index procedure
• Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy
• Known hypersensitivity or contraindication to contrast dye that cannot be adequately pre-medicated
• Known allergies against Paclitaxel or other components of the used medical devices
• Intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would be administered during the trial
• Platelet count \<100,000 mm3 or \>600,000 mm3
• Concomitant renal failure with a serum creatinine \>2.0 mg/dL
• Receiving dialysis or immunosuppressant therapy
• Life expectancy of less than one year
• Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.
• Woman who is pregnant or nursing.

Sponsors & Collaborators

• Hemoteq AG: lead
• CERES GmbH: collaborator
• coreLab Black Forest GmbH: collaborator

Study Sites (11)

Medical University, AKH

Vienna, 1090, Austria

Location

CHU Caen Côte de Nacre

Caen, 14000, France

Location

Hopital Europeen Georges-Pompidou (HEGP)

Paris, 75908, France

Location

Clinique Pasteur Toulouse

Toulouse, 31076, France

Location

Klinikum Arnsberg

Arnsberg, 59759, Germany

Location

Segeberger Kliniken

Bad Segeberg, 23795, Germany

Location

Klinikum Darmstadt GmbH

Darmstadt, 64283, Germany

Location

CardioVascular Center

Frankfurt, 60389, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Park-Krankenhaus

Leipzig, 04289, Germany

Location

Universitätsklinikum

Marburg, 35043, Germany

Location

Related Publications (1)

• Bausback Y, Willfort-Ehringer A, Sievert H, Geist V, Lichtenberg M, Del Giudice C, Sauguet A, Diaz-Cartelle J, Marx C, Strobel A, Schult I, Scheinert D; RANGER SFA Investigators. Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment. J Endovasc Ther. 2017 Aug;24(4):459-467. doi: 10.1177/1526602817710770. Epub 2017 May 31.

  PMID: 28558502 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Atherosclerosis; Arteriosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dierk Scheinert, M.D.

  University Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 17, 2013
• Study Start: January 7, 2014
• Primary Completion: June 16, 2016
• Study Completion: March 15, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (7); FR (3)