Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 289 for:    Best Disease

Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease (STRONG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03227822
Recruitment Status : Terminated (Unable to include the number of patients)
First Posted : July 24, 2017
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Marc van Sambeek, Catharina Ziekenhuis Eindhoven

Brief Summary:
Since the length of lesion seems to be negatively associated with stent patency due to restenosis, it is thought that the efficacy of treatment in patients with multiple (> 1) short (focal; > 1 and < 5 cm) SFA lesions can be improved by spot stenting as compared to the use of one long stent. This study proposes to evaluate the endovascular treatment for patients with SFA lesions by comparing two strategies for patients with extensive occlusive SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Procedure: Short spot stenting Procedure: Long lesion stenting Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease; a Pilot Study
Study Start Date : July 2013
Actual Primary Completion Date : February 1, 2015
Actual Study Completion Date : February 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: Short spot stenting
Short spot stenting
Procedure: Short spot stenting
Experimental: Long lesion stenting
Long lesion stenting
Procedure: Long lesion stenting



Primary Outcome Measures :
  1. absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PAOD (ABI <0.90 and/or a decline of >0.15 after exercise test), Rutherford category 2, 3 or 4
  • Multiple (>1) short (focal; >1 and < 5 cm) significant stenoses (≥ 50%) and/or occlusions in the superficial femoral artery
  • Eligible for endovascular treatment via short spot stenting and via long lesion stenting according to international guidelines
  • Unilateral occlusive disease
  • Age ≥ 18

Exclusion Criteria:

  • Patients with PAOD Rutherford category 5 and 6
  • Impaired inflow due to significant lesions in the arteries proximal to the SFA intended to treat
  • Bilateral lesions with treatment indication
  • Contra-indication for anticoagulant therapy
  • Renal insufficiency (MDRD < 50 ml/min)
  • Life expectancy < 6 months
  • Known contrast allergy
  • Pregnancy
  • Unable to complete a questionnaire in the home language

Layout table for additonal information
Responsible Party: Marc van Sambeek, MD, PhD, vascular surgeon, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT03227822     History of Changes
Other Study ID Numbers: STRONG SFA study
NL43610.060.13 ( Registry Identifier: NL43610.060.13 )
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases