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Completed

NCT Number: NCT00619788

FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study

This investigation is designed to demonstrate the efficacy and safety of the 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use in a controlled clinical investigation.

The scoring balloon is a semi-compliant balloon encircled by 3 spiral struts with a nitinol scoring element, which theoretically provides targeted scoring of lesions, by concentrating the dilation force thus minimizing barotrauma, elastic recoil and uncontrolled dissection. This may improve the outcome of the intervention and reduce the number of stents required.

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Key information

Conditions

Peripheral Arterial Occlusive Disease Peripheral Arterial Occlusive Disease 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Imelda Hospital, Bonheiden, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stenotic (>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries (primarily superficial femoral arteries - SFA)
  • Length of lesion >5 cm or 2 times the AngioSculpt balloon length (whichever is longer)
  • Reference vessel diameter should be 4.0-6.0 mm
  • Life altering claudication or critical limb ischemia (Rutherford 3-5)
  • No untreated inflow-limiting arterial lesions
  • At least single vessel run-off until the ankle
  • The patient must be > 18 years.
  • Life-expectancy of more than 12 months
  • The subject or legal guardian has been informed of the nature of the evaluation; agrees to its provisions and has signed informed consent
  • The patient is capable to follow all evaluation requirements.

Exclusion criteria

  • Patient refusing treatment
  • The reference segment diameter is not suitable for available catheter design
  • Length of lesion is ≥5 cm or requires more than two overlapping AngioSculpt balloon inflations (whichever is longer) to cover the entire lesion (however, more than two inflations are permitted within an acceptable lesion length)
  • The patient has a known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
  • The patient has a history of prior life-threatening contrast media reaction
  • The patient is currently enrolled in another investigational device or drug trial
  • The patient is currently breast-feeding, pregnant or intends to become pregnant

Treatment and study plan

4.0-5.0mm AngioSculpt Scoring Balloon Catheter

Device

The AngioSculpt Scoring Balloon Catheter is a line of innovative angioplasty catheters comprising an angioplasty balloon surrounded by a unique system of nitinol scoring elements. Creating focal concentrations of dilating force, the scoring elements score arterial lesions as the balloon expands.

Primary outcomes

  1. Complication Free Survival at 1 month post-procedure (complications = major amputations defined as amputations at or above the ankle, any cause of death and TLR)

    Time frame: 1 month

Secondary outcomes

  1. patency of the target lesion. Primary patency is defined as the absence of: a) target lesion revascularization (TLR); b) major amputation due to lesion restenosis or occlusion; c) conversion to bypass surgery and d) untreated significant stenosis on CFDU

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Flanders Medical Research Program

Network

Collaborators

  • AngioScore, Inc.

Registry information

Official study title

Prospective, Multicenter, Non-randomized Clinical Trial Investigating the Safety and Efficacy of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for the Treatment of Femoropopliteal Stenotic Disease.

Acronym: MASCOT

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Feb 21, 2008
Registry last updated
Jul 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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