Comparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.

Claudication Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359423
• Other study ID #: 1-2010-0065
• Status: Completed
• Phase: N/A
• First received: May 20, 2011
• Last updated: November 26, 2017
• Start date: September 26, 2011
• Est. completion date: August 10, 2017

Study information

• Verified date: November 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting in the treatment of long (≥80 mm) femoropopliteal artery lesions.

Study design :

• Prospective, randomized, multi-center study

• A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who meet all inclusion and exclusion criteria will be included.

• Patients will be randomized in a two by two factorial manner according to the strategy of stenting (long versus short stenting) and the additional use of cilostazol. Each randomization of the enrolled subjects will be done 1:1.

• Patients will be followed clinically for 1 year after the procedure.

• Angiographic or CT follow-up will be performed at 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 10, 2017
• Est. primary completion date: August 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

Clinical criteria:

1. Age 20 years of older

2. Symptomatic peripheral artery disease:

• Moderate or severe claudication (Rutherford category 2 or 3)

• Critical limb ischemia (Rutherford category 4 or 5)

3. Patients with signed informed consent

Anatomical criteria:

1. Target lesion length =80 mm by angiographic estimation

2. Stenosis of more than 50 percent or occlusion of the ipsilateral superficial femoral artery

3. At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.

Exclusion Criteria:

Clinical criteria

1. Acute critical limb ischemia

2. Severe critical limb ischemia (Rutherford category 6)

3. Major bleeding history within prior 2 months

4. Known hypersensitivity or contraindication to any of the following medications:

heparin, aspirin, clopidogrel or contrast agents

5. Age > 85 years

6. Severe hepatic dysfunction (> 3 times normal reference values)

7. Significant renal dysfunction (Serum creatinine > 2.0 mg/dl

8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis

9. LVEF < 40% or clinically overt congestive heart failure

10. Pregnant women or women with potential childbearing

11. Life expectancy <1 year due to comorbidity

Angiographic criteria

1. Previous bypass surgery or stenting of the superficial femoral artery

2. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)

Related Conditions & MeSH terms

• Claudication

Intervention

Drug:
• Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
• short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of binary restenosis	The rate of binary restenosis (stenosis of at least 50 percent of the luminal diameter) in the treated segment 12 months after intervention, as determined by computed tomographic angiography (CTA) or catheter angiography according to the stenting strategy	12months after the index procedure
Secondary	Ankle-brachial index, etc	Ankle-brachial index at 12 months according to the stenting strategy; Maximal walking distance at 12 months according to the stenting strategy; The rate of reintervention including repeat endovascular therapy or bypass surgery involving the target lesion; The rate of limb salvage at 12 months according to the stenting strategy; The rate of major adverse cardiovascular events (MACE) at 12 months according to the stenting strategy	at 12 months according to the stenting strategy