Clinical trial NCT01994798: Rapid Exchange Devices Observational Registry.
Official title: Prospective, Non-randomized, Multicentre, Observational Registry to Assess Clinically Relevant Benefit of Performing the Whole PTA Procedure Using the Rapid Exchange (RX) Devices.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral (Lowr Extremity) Arterial Disease.
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with one lesion located in Superficial Femoral Artery(SFA) or popliteal artery planned to be treated as per hospital practice with plain old balloon angioplasty and nitinol stent using monorail (rapid exchange) delivery system.

Brief summary: This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology.

Detailed description: This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology

Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic one or two legs ischemia, requiring treatment of SFA or popliteal artery
* Rutherford classification 2-5
* Single lesion with recoiling/dissection/restenosis after balloon angioplasty or de novo lesions with stenosis or occlusion,
* Target vessel reference diameter ≥4mm and ≤7mm (by visual estimate)
* At least one patent (less than 50% stenosis) tibioperoneal run-off vessel confirmed by baseline angiography
* Patient is suitable candidate for femoral-popliteal artery bypass surgery

Exclusion Criteria:

* Female of child-bearing potential.
* Previous bypass surgery
* In stent restenosis as a target lesion
* Scheduled staged procedure of multiple lesions within the ipsilateral iliac or popliteal arteries within 30 days after index procedure.
* Co-existing aneurysmal disease of the abdominal aorta, iliac or popliteal arteries
* Acute thrombophlebitis or deep venous thrombosis
* Hemodynamic instability
* Untreated inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion),
* Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
* Known intolerance to study medications, contrast agents or nitinol.

Primary outcomes:
measure: Safety: composite of all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month
timeFrame: From start up to 30 Days post procedure.
measure: Total contrast media volume given during the procedure.
timeFrame: During procedure
Secondary outcomes:
measure: Total duration of the procedure
timeFrame: During procedure
measure: Total fluoroscopy time
timeFrame: During procedure
measure: Total radiation dose given
timeFrame: During procedure
measure: Technical success defined as a successful access and balloon angioplasty followed by stent placement with achieved recanalization determined by less than 30% residual stenosis by angiography at the baseline procedure.
timeFrame: Pre- and post-procedure
measure: Clinical success defined as technically successful procedure without the events considered in safety composite endpoint (all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month.
timeFrame: During procedure
measure: Total acute complication rate defined as any device- or procedure- related complication up to 1 month post procedure.
timeFrame: Up to 30 Days post procedure
measure: Total acute device related complication rate defined as any device complication up to 1 month post procedure.
timeFrame: Up to 30 Days post procedure
measure: Ankle-Brachial Index (ABI) improvement at 30 days.
timeFrame: 30 Days post procedure
measure: Improvement of the Rutherford index at 30 days.
timeFrame: 30Days post procedure
measure: Walking distance at 30 days compared with walking distance before procedure.
timeFrame: 30 Days post procedure
measure: Bleeding complication as per BARC definitions.
timeFrame: Up to 30 days post procedure
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis (OLV) Aalst
city: Antwerp
country: Belgium
facility: GasthuisZusters Antwerpen (GZA) Ziekenhuizen
city: Auvelais-Val de Sambre
country: Belgium
facility: Centre Hospitalier Régional (CHR) du Val de Sambre
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire (CHU) Liège
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta de Girona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: Centre Hospitalier Universitaire (CHU) Liège
name: Christophe Martinez
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Dr. Josep Trueta de Girona
name: Omar Andrés Navarro
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Regionale di Lugano
name: Josua Van den Berg
role: PRINCIPAL_INVESTIGATOR
References: