Condition category
Circulatory System
Date applied
13/06/2012
Date assigned
30/07/2012
Last edited
25/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Atherosclerosis is a condition where the blood vessels (arteries) become narrow. Atherosclerosis affecting the superficial femoral artery (a large artery in the thigh) may cause pain and reduced blood flow to the leg, leading to serious complications such as tissue loss, amputation and even death. Surgery can be used to restore the blood flow, relieve symptoms and prevent or delay these complications. Percutaneous transluminal angioplasty (PTA) is a procedure to open up the blocked artery using a small plastic tube (catheter) with a balloon and a small mesh tube (stent) at the end. When the tube is in place, it inflates to open the artery. The stent expands so that it acts as a scaffold and holds open the artery. However, the artery becomes narrow again (restenosis) in 45% of patients at 2 years follow-up. Using balloons covered in paclitaxel/shellac may prevent the artery walls from thickening. The aim of this study is to demonstrate whether there is a beneficial effect of using paclitaxel/shellac covered balloons over standard PTA on the occurrence of restenosis.

Who can participate?
Patients over 18 years old with atherosclerosis of the superficial femoral artery

What does the study involve?
Participants are randomly allocated to one of two groups. The intervention group undergo PTA using the paclitaxel/shellac covered balloons followed by placement of a stent. The control group undergo standard PTA followed by placement of a stent. Restenosis rates are compared at 1, 6, 12 and 24 months follow-up and during unplanned visits.

What are the possible benefits and risks of participating?
A possible benefit is reduction of restenosis. The risks are the same as standard PTA and stenting. The use of similar balloons is safe in coronary (heart) artery interventions.

Where is the study run from?
St Antonius Hospital Nieuwegein (Netherlands)

When is the study starting and how long is it expected to run for?
June 2012 to January 2014

Who is funding the study?
St Antonius Hospital Nieuwegein (Netherlands)

Who is the main contact?
Dr Jean-Paul P M de Vries
j.vries@antoniusziekenhuis.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jean-Paul P M de Vries

ORCID ID

Contact details

PO Box 2500
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
-
j.vries@antoniusziekenhuis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL39391.100.12

Study information

Scientific title

RAndomized trial of Legflow® PaclItaxel Eluting Balloon (LPEB) with stentplacement vs. stanDard percutaneous transluminal angioplasty (PTA) with stentplacement for the treatment of intermediate (>5 cm and < 15 cm) and long (>15 cm) lesions of the superficial femoral artery (SFA): the RAPID trial

Acronym

RAPID

Study hypothesis

Treatment with the Legflow® Paclitaxel eluting balloon in combination with Nitinol stents will lead to significantly lower restenosis rates when compared to conventional uncoated balloon angioplasty combined with the same Nitinol stents in treatment of intermediate (>5 cm and < 15 cm) and long-segment (> 15 cm) SFA lesions.

Ethics approval

Ethics Committee of the St. Antonius Hospital Nieuwegein, 27/04/2012, ref: R-12.009

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Atherosclerotic lesions of the superficial femoral artery

Intervention

The intervention group will undergo endovascular dilatation of intermediate and long lesions of the SFA with the LegFlow® Paclitaxel eluting balloon followed by placement of a nitinol selfexpandable stent (Supera®, IDEV inc., Webster TX).

The control group will undergo endovascular dilatation of the SFA with standard PTA followed by placement of the same Supera® stent.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Absence of binary restenosis, measured with duplex ultrasound (DUS), and if indicated with digital subtraction angiography (DSA), at 1, 6, 12 and 24 months follow-up and unplanned visits

Secondary outcome measures

1. Immediate outcome: Ankle Brachial Index (ABI), toe pressures, angiography
2. Clinical outcome: periferal artery questionnaire
3. Hemodynamic outcome: ankle-brachial index (ABI), Toe pressures
4. Reocclusion rate: DUS, DSA
5. Target-lesion revascularization: Follow-up
6. Target-extremity revascularization: Follow-up
7. Mortality rate: Follow-up
8. Amputation rate : Follow-up
9. Rate of device-specific problems: Follow-up with DUS, DSA when indicated

All endpoints will be scored at regular follow-up and during unplanned visits.

Overall trial start date

01/06/2012

Overall trial end date

01/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age over 18
2. Symptomatic, atherosclerotic intermediate (>5 cm and < 15 cm) and long (>15 cm) lesions of the superficial femoral artery.
3. Rutherford class 2-6
4. At least one patent below-the-knee artery with uninterrupted flow to the pedal arch
5. Signed informed consent
6. Randomization will be performed after advancement of a guide wire across the target SFA lesion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

176

Participant exclusion criteria

1. Life expectancy less than one year
2. Previous endovascular or surgical treatment of the target superficial femoral artery
3. Inability to comply with the follow-up schedule.
4. Mental disability that hinders the ability to understand and comply with the informed consent
5. Pregnancy or breast-feeding
6. Severe renal failure [estimated glomerular filtration rate (e-GFR) <30 mL/min/1.73 m^2]
7. Known allergy to iodinated contrast agents
8. Contra-indication for anti-coagulation (aspirin as well as clopidogrel)
9. (Acute) limb ischemia caused by SFA or popliteal artery aneurysmal disease
10. Obstruction caused by SFA or popliteal artery dissections

Recruitment start date

01/06/2012

Recruitment end date

01/01/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

PO Box 2500
Nieuwegein
3435 CM
Netherlands

Sponsor information

Organisation

St Antonius Hospital Nieuwegein (Netherlands)

Sponsor details

PO Box 2500
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
-
j.vries@antoniusziekenhuis.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

St. Antonius Ziekenhuis

Alternative name(s)

St. Antonius Hospital, Sint Antonius Ziekenhuis

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23537403

Publication citations

  1. Protocol

    Karimi A, de Boer SW, van den Heuvel DA, Fioole B, Vroegindeweij D, Heyligers JM, Lohle PN, Elgersma O, Nolthenius RP, Vos JA, de Vries JP, Randomized trial of Legflow(®) paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): study protocol for a randomized controlled trial., Trials, 2013, 14, 87, doi: 10.1186/1745-6215-14-87.

Additional files

Editorial Notes

25/05/2017: Plain English summary added.