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Completed

NCT Number: NCT01587482

PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

Nowadays, stenting is became a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up to evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of SFA atherosclerotic lesions.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years old
  • Symptomatic patient according to Rutherford Class 1, 2, 3, 4 or 5
  • Clinical degradation by at least 1 Rutherford stage or absence of healing of all skin lesions
  • Symptoms related to SFA ISR defined by PSVR > 2.4 within 3 to 24 months after SFA stenting of de novo atherosclerotic lesions. Each patient may have either one or both limbs treated in the study
  • The target ISR lesion is fully comprised between the origin of the SFA and distally the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection)
  • Adequate SFA inflow and outflow either pre-existing or successfully re-established (outflow defined as patency of at least one infragenicular artery)
  • The target lesion must no extend beyond the stent margin
  • Successful crossing of the target lesion, inflow and outflow lesions with a guidewire
  • Patient belongs to the French health care system
  • Written informed consent

Exclusion criteria

  • No atheromatous disease
  • Asymptomatic lesion
  • Known allergies to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or paclitaxel
  • Acute limb ischemia
  • Patient on oral anticoagulation therapy
  • Target lesion requires / has been pre-treated with alternative therapy such as: DES, laser, atherectomy, cryoplasty, cutting/scoring balloon, etc.
  • Life expectancy < 1 year
  • Patient involved in another trial
  • Refusing patient
  • Pregnancy

Treatment and study plan

PacLitaxel Eluting Balloon Application

Procedure

Stenting is a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR.

Primary outcomes

  1. Target Lesion Revascularization (TLR)

    Time frame: at 1 year

Secondary outcomes

  1. Major Adverse Events through

    Time frame: at 1 year

  2. Target extremity revascularization (TER)

    Time frame: at 1, 3, 6, 9, 12 and 18 months after surgery

  3. clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization

    Time frame: at 1, 3, 6, 9, 12 and 18 months

    to assess primary maintenance of clinical improvement

  4. peak systolic velocity index without Target Lesion Revascularization

    Time frame: at 1, 3, 6, 9, 12 and 18 months

    to assess primary patency

  5. Quality of life assessment by EQ5D questionnaire

    Time frame: at 1, 3, 6, 9, 12 and 18 mois after surgery

  6. post-angioplasty restenosis

    Time frame: at 1, 3, 6, 9, 12 and18 months after surgery

  7. drug relief success without balloon break

    Time frame: during surgery

  8. Length of hospitalization stay

    Time frame: at 1 year

  9. clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery

    Time frame: at 1, 3, 6, 9, 12 and 18 months

    to assess secondary maintenance of clinical improvement

  10. peak systolic velocity index

    Time frame: at 1 year

    to assess secondary patency

  11. intra-stent restenosis

    Time frame: at 1, 3, 6, 9, 12 and 18 months after surgery

    significant whether restenosis >50% and peak systolic velocity index > 2.4

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: PLAISIR

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Apr 30, 2012
Registry last updated
May 20, 2016

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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