Efficacy and Safety Comparison of the Open Surgical and Endovascular Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D.

Atherosclerosis Clinical Trial

Official title:

Efficacy and Safety Comparison of the Open (Femoral-popliteal Proximal Bypass) and Endovascular (Recanalization With Angioplasty and Stenting With Biomimetic Interwoven Nitinol Stent) Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588571
• Other study ID #: Sosudi2
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Andrey A Karpenko, PHD, MD
• Phone: +79139504100
• Email: andreikarpenko[@]rambler.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Some studies with intervowen nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was > 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (>200 mm).

This is a prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure. It is planned to recruit 110 patients (55 patients in each group). Observation period 2 years. Primary endpoint:

-The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency).

Secondary endpoints:

• Clinical efficacy of the method of surgical treatment after 24 months (MALE);

• Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE);

• Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire);

• Evaluation of prognostic factors for adverse outcomes after surgical treatment.

Description:

Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Some studies with interwoven nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was > 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (>200 mm).

This is a prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure.

The analysis of literature data showed, that two-year primary patency after endovascular revascularization using a nitinol stent in long lesions was 60%. At the same time, the two-year primary patency after the femoropopliteal proximal bypass was 56% (Enzmann et al. Nitinol stent versus bypass in long femoropopliteal lesions: 2-year results of a randomized controlled trial. JACC: Cardiovascular Interventions. 2019 Dec 23; 12 (24): 2541-9.). Considering these data, it should be assumed that the use of biomimetic interwoven nitinol stents will slightly improve the primary patency parameters within 2 years in the stenting group. The 2-year primary patency after stenting of the femoropopliteal segment with an interwoven nitinol stent was 76% (Scheinert et al., 2011). A power analysis was performed to calculate the sample size of the "non-inferiority" design for a study power of 80%, a type 1 error probability of 5%, and a non-inferiority margin of 10%. It is planned to recruit 110 patients (55 patients in each group). The observation period of 2 years. Primary endpoint:

-The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency).

Secondary endpoints:

• Clinical efficacy of the method of surgical treatment after 24 months (MALE);

• Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE);

• Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire);

• Evaluation of prognostic factors for adverse outcomes after surgical treatment. Screening It is performed in patients with a verified diagnosed occlusive lesion of the femoropopliteal segment above the knee joint (type D according to the TASC II classification), with chronic ischemia of the lower extremities of 3-6 categories according to Rutherford.

• Assessment of inclusion/exclusion criteria

• Assigning a patient number

Study inclusion Collecting baseline information about the patient (history, including information about concomitant therapy, data from the initial physical examination, ultrasound data of the lower limb arteries, CT -arteriography data, assessment of the quality of life using the SF-36 questionnaire. Randomization using the envelope method to one group or another.

Group 1: Femoropopliteal proximal bypass; Group 2: Recanalization of prolonged occlusion of the arteries of the femoral-popliteal segment above the knee joint with angioplasty and stenting with a biomimetic interwoven nitinol stent.

Follow up period; 6, 12, and 24 months.

Performed:

Triplex ultrasound of one lower limb (restenosis, thrombosis, stent breakage);

• Leg's roentgenography for the stenting group in two projections, for patients in whom a stent breakage is suspected according to ultrasound;

• Consultation with a cardiovascular surgeon.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age> 18 years;

• Symptomatic lesion (Rutherford category 3 - 6);

• Atherosclerotic prolonged occlusive lesion of the femoropopliteal arterial segment above the knee, classified by TASC II as type D, confirmed by computed tomography or arteriography;

• De novo lesion;

• Patient informed consent.

Exclusion Criteria:

• Age < 18 years old;

• Potentially pregnant women;

• Asymptomatic lesion;

• Acute ischemia;

• Not de novo lesion;

• Severe comorbidity with a life expectancy of fewer than 2 years;

• Contraindications to antiplatelet therapy (double antiplatelet therapy is required for at least 2 months after the intervention);

• Patient participation in another clinical trial;

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Atherosclerosis
• Ischemia
• Ischemia Limb
• Popliteal Artery Occlusion
• Superficial Femoral Artery Occlusion

Intervention

Procedure:
• Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stent
Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Transluminal or subintimal recanalization of the occluded arterial segment is performed with a hydrophilic guidewire. Next, balloon angioplasty of the recanalized segment is performed. After control angiography, a biomimetic interwoven nitinol stent is placed throughout the lesion. Drug therapy includes pre-procedure aspirin (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed aspirin (100 mg per day) for a long time and clopidogrel (75 mg per day) for 3 months.
• Femoropopliteal proximal bypass
Under general anesthesia, 2 standard open surgical approaches are performed: first - to the common femoral artery, superficial femoral artery, and deep femoral artery; the second - to the first portion of the popliteal artery. After systemic heparinization, clamps are applied to the arteries. A longitudinal arteriotomy of the popliteal artery is performed, and a distal end-to-side anastomosis is formed between the artery and the shunt. Next, the shunt is passed into the groin wound. Longitudinal arteriotomy of the common femoral artery. A proximal end-to-side anastomosis is formed between the shunt and the common femoral artery. Surgical hemostasis wound drainage and layer-by-layer wound closure are performed. Drug therapy includes pre-procedure aspirin (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed aspirin (75-100 mg per day) for a long time.

Locations

Country	Name	City	State
Russian Federation	Meshalkin Research Institute of Pathology of Circulation	Novosibirsk	Novosibirsk Area

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary patency	primary patency is defined as absence of occlusion or flow-limiting stenosis (peak systolic velocity [PSV] ratio >2.5) of the treated segment including 1 cm proximal and distal of the anastomosis.	24 months
Primary	primary assisted patency	primary assisted patency is defined as a secondary procedure is performed to prevent failure (in a flow-limiting stenosis [PSV ratio >2.5] in a still-patent segment of stent or bypass, including the anastomoses.	24 months
Primary	secondary patency	secondary patency is defined as a secondary procedure performed for graft or stent occlusion in an afterward patent vessel.	24 months
Secondary	MALE	Major adverce limb events	24 months
Secondary	Safety of the surgical treatment in the early postoperative period	hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area	30 days
Secondary	MACE	major adverce cardiovascular events, deaths	24 months
Secondary	Assessment of the quality of life	SF-36 questionary	24 months