Advertisement

Topics

Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery

2014-08-27 03:12:48 | BioPortfolio

Summary

Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass. If the great saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Now, the skill of endovascular treatment is developing rapidly, and lots of doctors think most of such patients could be treated with stent. The purpose of this trial is to compare stent and artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive treatment of stent can be considered in such patients.

Description

This is a multi-center, prospective, randomized, controlled trial to compare the therapeutic effect of stent and artificial blood vessel bypass to chronic long occlusion of the superficial femoral artery. Totally 200 patients will be entered into the trial. The study population will consist of patients with long superficial femoral stenosis and occlusion lesion (≥15 cm), presenting symptomatic ischemia(Rutherford 3-6). The lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.

Trial participants will be randomized to either stent group or artificial blood vessel bypass group.

Patients will be followed up for 3 years. Study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure.

This study will be conducted at 3 centers in Beijing, China.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Arterial Occlusive Diseases

Intervention

stent, femoral-popliteal bypass with artificial blood vessel

Location

Peking Union Medical College Hospital
Beijing
Beijing
China
100032

Status

Recruiting

Source

Peking Union Medical College Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:48-0400

Clinical Trials [2089 Associated Clinical Trials listed on BioPortfolio]

Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusive Disease

This study is a comparison of two different ways to treat blockage in the artery of the thigh. The first is an older way with incisions in the groin and just above the knee. A plastic tu...

Long Segment Lesion Peripheral Artery Revascularization Feasibility Study

The primary objective of the feasibility study is to evaluate the safety and effectiveness of the PQ Bypass Stent Graft System in the treatment of atherosclerotic lesions of the native sup...

Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis

This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment ...

Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project

To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA...

Natural Vascular Scaffold (NVS) Therapy

The NVS Therapy is being studied to evaluate the safety and efficacy of retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arter...

PubMed Articles [9691 Associated PubMed Articles listed on BioPortfolio]

Covered stent treatment of a chronically thrombosed popliteal artery aneurysm in the setting of critical limb ischemia following multiple failed bypass operations.

Endovascular salvage of failed surgical bypasses has been scantly reported for treatment of infrainguinal occlusive disease. While catheter-directed thrombolysis and/or mechanical thromboembolectomy h...

Endoscopic versus open great saphenous vein harvesting for femoral to popliteal artery bypass.

Conflicting data exist on outcomes of open vein harvest (OVH) and endoscopic vein harvest (EVH) for infrainguinal bypass. The purpose of this study was to compare outcomes between OVH and EVH in femor...

Development of Angiosarcoma in a Saphenous Vein Graft Following Femoral to Above-knee Popliteal Artery Bypass.

Angiosarcoma is an exceedingly rare and aggressive neoplasm. Due to early metastasis even in low-grade tumors, it is associated with poor survival. We report a late development of an angiosarcoma in a...

Postoperative continuous catheter-infused local anesthetic reduces pain scores and narcotic use after lower extremity revascularization.

Objective Postoperative pain following lower extremity revascularization procedures is traditionally controlled with narcotic administration. However, this may not adequately control the pain and puts...

Margination of Stiffened Red Blood Cells Regulated By Vessel Geometry.

Margination of stiffened red blood cells has been implicated in many vascular diseases. Here, we report the margination of stiffened RBCs in vivo, and reveal the crucial role of the vessel geometry in...

Medical and Biotech [MESH] Definitions

Surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent.

The continuation of the femoral artery coursing through the popliteal fossa; it divides into the anterior and posterior tibial arteries.

The vein formed by the union of the anterior and posterior tibial veins; it courses through the popliteal space and becomes the femoral vein.

The vein accompanying the femoral artery in the same sheath; it is a continuation of the popliteal vein and becomes the external iliac vein.

Diversion of the flow of blood from the entrance of the right atrium directly to the aorta (or femoral artery) via an oxygenator thus bypassing both the heart and lungs.

More From BioPortfolio on "Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Stent
A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body.  A stent is placed in an artery as part of a procedure called angioplasty. &...


Searches Linking to this Trial