Rapid Exchange Devices Observational Registry. (RXRegistry)

• ClinicalTrials.gov Identifier: NCT01994798
• Recruitment Status: Unknown
• First Posted: November 26, 2013
• Last Update Posted: April 26, 2016
• Sponsor: Terumo Europe N.V.
• Information provided by (Responsible Party): Terumo Europe N.V.

Study Description

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.

Condition or disease
Peripheral (Lowr Extremity) Arterial Disease.

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

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 525 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Target Follow-Up Duration: 30 Days
• 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 Start Date: November 2013
• Estimated Primary Completion Date: September 2016
• Estimated Study Completion Date: December 2016

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Safety: composite of all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month [ Time Frame: From start up to 30 Days post procedure. ]
2. Total contrast media volume given during the procedure. [ Time Frame: During procedure ]

Secondary Outcome Measures :

1. Total duration of the procedure [ Time Frame: During procedure ]
2. Total fluoroscopy time [ Time Frame: During procedure ]
3. Total radiation dose given [ Time Frame: During procedure ]
4. 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. [ Time Frame: Pre- and post-procedure ]
5. 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. [ Time Frame: During procedure ]
6. Total acute complication rate defined as any device- or procedure- related complication up to 1 month post procedure. [ Time Frame: Up to 30 Days post procedure ]
7. Total acute device related complication rate defined as any device complication up to 1 month post procedure. [ Time Frame: Up to 30 Days post procedure ]
8. Ankle-Brachial Index (ABI) improvement at 30 days. [ Time Frame: 30 Days post procedure ]
9. Improvement of the Rutherford index at 30 days. [ Time Frame: 30Days post procedure ]
10. Walking distance at 30 days compared with walking distance before procedure. [ Time Frame: 30 Days post procedure ]
11. Bleeding complication as per BARC definitions. [ Time Frame: Up to 30 days post procedure ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Locations

Belgium

Onze-Lieve-Vrouwziekenhuis (OLV) Aalst

Aalst, Belgium

GasthuisZusters Antwerpen (GZA) Ziekenhuizen

Antwerp, Belgium

Centre Hospitalier Régional (CHR) du Val de Sambre

Auvelais-Val de Sambre, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

Centre Hospitalier Universitaire (CHU) Liège

Liège, Belgium

Spain

Hospital Universitario de Burgos

Burgos, Spain

Hospital Universitari Dr. Josep Trueta de Girona

Girona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Sponsors and Collaborators

Terumo Europe N.V.

Investigators

• Principal Investigator: Christophe Martinez; Centre Hospitalier Universitaire (CHU) Liège
• Principal Investigator: Omar Andrés Navarro; Hospital Universitari Dr. Josep Trueta de Girona
• Principal Investigator: Josua Van den Berg; Ospedale Regionale di Lugano

More Information

Additional Information:

• Responsible Party: Terumo Europe N.V.
• ClinicalTrials.gov Identifier: NCT01994798
• Other Study ID Numbers: T122E2
• First Posted: November 26, 2013
• Last Update Posted: April 26, 2016
• Last Verified: April 2016