Trial record 10 of 213 for:    Open Studies | angioplasty

Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries(SENS-BTK)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Korea University Guro Hospital
Sponsor:
Information provided by (Responsible Party):
Seung Woon Rha, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT01644487
First received: July 17, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

The objectives of this study are to compare directly conventional balloon angioplasty alone versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty with self-expanding stent is superior to conventional balloon angioplasty - in the infrapopliteal arterial occlusive lesions of critical limb ischemia patients by collecting and analyzing the cases of each patient group in a prospective multicenter randomized clinical trial, and to clarify main factors affecting mid- and long-term clinical effects of angioplasty with self-expanding stent in the infrapopliteal arteries.

Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior to conventional PTA in the aspect of vascular restenosis rate.


Condition Intervention Phase
Critical Limb Ischemia
Infrapopliteal Arterial Occlusive Disease
Device: self-expanding nitinol stent
Device: balloon angioplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries Following Successful Balloon Angioplasty Trial (Korean Vascular Intervention Multicenter Study)

Resource links provided by NLM:


Further study details as provided by Korea University Guro Hospital:

Primary Outcome Measures:
  • Angiographic binary restenosis rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 232
Study Start Date: August 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Primary stenting
A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty
Device: self-expanding nitinol stent
A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty
Other Name: Xpert stent
Active Comparator: Balloon only
A group of patients who will undergo routine conventional balloon angioplasty alone without stenting
Device: balloon angioplasty
A group of patients who will undergo routine conventional balloon angioplasty alone without stenting

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic critical limb ischemia (Rutherford 4 - 6)
  • Patients with signed informed consent
  • Target lesion length < 8 cm by angiographic estimation
  • Stenosis of >50% or occlusive atherosclerotic lesion of the ipsilateral infrapopliteal artery
  • Reference vessel diameter should be 2.0-4.5 mm

Exclusion Criteria:

  • Patient has a known allergy to heparin, aspirin, or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
  • Patient takes warfarin
  • Patient has a history of previous life-threatening contrast media reaction
  • Patient is currently enrolled in another investigational device or drug trial
  • Patient is currently breast-feeding, is pregnant, or intends to become pregnant
  • Patient is mentally ill or retarded
  • Acute critical limb ischemia
  • Major bleeding history within prior 2 months
  • Severe hepatic dysfunction (> 3 times normal reference values)
  • Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
  • Life expectancy <1 year due to comorbidity
  • Reference segment diameter is not suitable for available stent design
  • Previously implanted stent(s) or PTA at the same lesion site
  • Inflow-limiting arterial lesions left untreated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644487

Contacts
Contact: Seung-Woon Rha, MD, PhD 82-2-2626-3020 swrha617@yahoo.co.kr
Contact: Yun-Hyeong Cho, MD, PhD 82-31-810-6776 princette@hanmail.net

Locations
Korea, Republic of
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of, 152-703
Contact: Seung-Woon Rha, MD, PhD    82-2-2626-3020    swrha617@yahoo.co.kr   
Contact: Yun-Hyeong Cho, MD, PhD    82-31-810-6776    princette@hanmail.net   
Principal Investigator: Seung-Woon Rha, MD, PhD         
Sponsors and Collaborators
Korea University Guro Hospital
  More Information

No publications provided

Responsible Party: Seung Woon Rha, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT01644487     History of Changes
Other Study ID Numbers: EV-10302
Study First Received: July 17, 2012
Last Updated: July 17, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Ischemia
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014