ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries

Peripheral Vascular Diseases Clinical Trial

Official title:

Non-Randomized, Prospective, Multi-center Evaluation of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System for Occluded or Stenotic Superficial Femoral or Proximal Popliteal Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180505
• Other study ID #: 04-100
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 23, 2010
• Start date: March 2005
• Est. completion date: October 2009

Study information

• Verified date: February 2010
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.

Description:

The treatment of stenosis in superficial femoral arteries and/or proximal popliteal arteries with stenting is associated with high restenosis rates, especially with the first generation stents (stainless steel). Currently, self-expandable nitinol stents are commercialized which lead to higher primary patency rates as compared to the first generation stents, even in longer lesions. However, until now most data available are retrospective and uni-center. The ASSESS study is a prospective multi-center study investigating the performance (restenosis rate, patency rates) of the ABSOLUTE™. 035 peripheral self-expandable stent in longer lesions (lesion length from 4.00 mm to 200.00 mm).

Moreover, literature shows stent fracture in nitinol stents, with a possible clinical relationship. For this reason, the ASSESS study will analyze the stent fractures of the ABSOLUTE™ stent, and a possible relationship between stent fracture and restenosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2009
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters:

• 10 mm distal to the origin of the profunda femoris (= 10 mm from the femoral bifurcation in the SFA) and

• 20 mm from the proximal margin of the intercondylar fossa.

• Patients must have symptomatic leg ischemia, requiring treatment of the superficial femoral/proximal popliteal vessel

• Target vessel reference diameter visually estimated to be > 4.0 mm and < 7.0 mm

• Target lesion length visually estimated to be > 40 mm and < 200 mm

• If the patient has a contralateral SFA or contralateral proximal popliteal lesion, this lesion can be treated as a non-target lesion. The time and way of treatment of the non-target lesion will be left up to the discretion of the investigator

• At least one-vessel run-off to the foot confirmed by baseline angiography

• Patent common iliac artery, common femoral artery and profunda confirmed by baseline angiography. The patent common iliac artery can be obtained during the index procedure by a successful treatment prior to the treatment of the target lesion. Successful treatment being defined as attainment of final residual diameter stenosis of < 30% without death, stroke, bleeding requiring > 2 units transfusion, or any other complication which was device or procedure related.

• Patient is acceptable candidate for femoral-popliteal artery bypass surgery

Exclusion Criteria:

• Previous ipsilateral femoro-popliteal or femoro-tibial surgery

• Presence of a stent in the target vessel

• Prescheduled staged procedures of multiple lesions within the ipsilateral iliac or ipsilateral popliteal arteries within 30 days after the index procedure

• Co-existing aneurysmal disease of the abdominal aorta or iliac or popliteal arteries

• Acute thrombophlebitis or deep vein thrombus

• Any immunosuppressive disorders, groin infection, or acute systemic infection due to any cause or any viral or bacterial infection

• Significant gastrointestinal (GI) bleed within the past month that would contraindicate the use of anti-platelet therapy

• Hemodynamic instability

• Target lesion is restenotic from previous intervention

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
A prospective, non-randomized, multi-center study to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Follow up at 30, 180, 270, 365 days and 2 years.

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Klagenfurt	Klagenfurt
Austria	Allgemeines Krankenhaus der Stadt Wien (AKH Wien)	Wien
Belgium	CHR de Namur	Namur
France	Polyclinique Louis Pasteur	Essey les Nancy
France	Hôpital Pontchaillou- CHU	Rennes Cedex
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Universitäres Herz & Gefässzentrum Hamburg	Hamburg
Germany	Herzzentrum Leipzig	Leipzig
Greece	Papageorgiou Hospital	Thessaloniki
Italy	Nuovo Ospedale Civile Sant' Agostino	Baggiovara (Modena)
Italy	Casa di Cura Montevergine	Mercogliano
Italy	Policlinico San Matteo	Pavia
Spain	Hospital de Donostia	Donostia-San Sebastian

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Greece,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restenosis rate (diameter stenosis = 50% as determined by Duplex ultrasound).		At 180 days	No
Secondary	Clinically driven target lesion revascularization		at 12 and 24 month follow-up	No
Secondary	Target lesion primary, primary assisted and secondary patency rates		at 6, 12 and 24 month follow-up	No
Secondary	Major complications		at 1, 6, 12 and 24 month follow-up	Yes
Secondary	Angiographic binary restenosis rate in a subset of patients		at 9 month follow-up	No
Secondary	Device and procedure success		Acute	No
Secondary	Vascular and bleeding complications (local and puncture site)		1, 6, 12, 24 months	Yes
Secondary	Stent fracture determined by biplane X-ray		at 12 month follow-up	No
Secondary	Restenosis rate at 365 days, and 2 years (diameter stenosis = 50% as determined by Duplex ultrasound)		365 days and 2 years	No