PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

Peripheral Arterial Disease Clinical Trial

— PLAISIR  

Official title:

PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587482
• Other study ID #: PROG/11/79
• Status: Completed
• Phase: N/A
• First received: February 15, 2012
• Last updated: May 19, 2016
• Start date: December 2011
• Est. completion date: January 2015

Study information

• Verified date: May 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• PacLitaxel Eluting Balloon Application
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.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Revascularization (TLR)		at 1 year	No
Secondary	Major Adverse Events through		at 1 year	No
Secondary	Target extremity revascularization (TER)		at 1, 3, 6, 9, 12 and 18 months after surgery	No
Secondary	clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization	to assess primary maintenance of clinical improvement	at 1, 3, 6, 9, 12 and 18 months	No
Secondary	peak systolic velocity index without Target Lesion Revascularization	to assess primary patency	at 1, 3, 6, 9, 12 and 18 months	No
Secondary	Quality of life assessment by EQ5D questionnaire		at 1, 3, 6, 9, 12 and 18 mois after surgery	No
Secondary	post-angioplasty restenosis		at 1, 3, 6, 9, 12 and18 months after surgery	No
Secondary	drug relief success without balloon break		during surgery	No
Secondary	Length of hospitalization stay		at 1 year	No
Secondary	clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery	to assess secondary maintenance of clinical improvement	at 1, 3, 6, 9, 12 and 18 months	No
Secondary	peak systolic velocity index	to assess secondary patency	at 1 year	No
Secondary	intra-stent restenosis	significant whether restenosis >50% and peak systolic velocity index > 2.4	at 1, 3, 6, 9, 12 and 18 months after surgery	No