Legflow® Paclitaxel Eluting Balloon (LPEB) with stentplacement versus standard percutaneous transluminal angioplasty with stentplacement for the treatment of occlusive disease of the superficial femoral artery
| ISRCTN | ISRCTN47846578 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47846578 |
| Protocol serial number | NL39391.100.12 |
| Sponsor | St Antonius Hospital Nieuwegein (Netherlands) |
| Funder | St. Antonius Ziekenhuis |
- Submission date
- 13/06/2012
- Registration date
- 30/07/2012
- Last edited
- 25/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
PO Box 2500
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
| j.vries@antoniusziekenhuis.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | RAPID |
| Study objectives | 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(s) | Ethics Committee of the St. Antonius Hospital Nieuwegein, 27/04/2012, ref: R-12.009 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Immediate outcome: Ankle Brachial Index (ABI), toe pressures, angiography |
| Completion date | 01/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 176 |
| Total final enrolment | 160 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 01/01/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3435 CM
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2017 | 25/02/2021 | Yes | No |
| Protocol article | protocol | 28/03/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/02/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
25/05/2017: Plain English summary added.
