Covered Stents Versus Bare-Metal Stents

NCT02428582 | Unknown

• 1 other identifier: MEC-2013-476
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the outcome of revascularisation the gastrointestinal arteries using covered stents compared to bare-metal stents in patients with CGI.

Conditions

Gastrointestinal Vascular Conditions; Arteriosclerosis; Lifestyle-related Condition; Stenosis; Vascular Insufficiency; Necrosis

Keywords

endovascular treatment; arterial occlusive disease; bare metal stent; polytetrafluoroethylene covered stent

Outcome Measures

Primary Outcomes (1)

• The difference of primary and secondary patency rates of covered stents versus bare-metal stents to treat atherosclerotic CGI disease.

  12 to 24 months

Secondary Outcomes (5)

• The freedom from restenosis after 6-, 12- and 24- months after stent implantation

  6 to 24 month

• The freedom from symptom recurrence after 6-, 12- and 24- months after stent implantation

  6 to 24 month

• The freedom from reintervention after 6-, 12- and 24- months after stent implantation

  6 to 24 month

• The clinical outcome in terms of quality of life and therapeutic and total costs after 6-, 12- and 24- months after stent implantation

  6 to 24 month

• The clinical outcome in terms therapeutic and total costs after 6-, 12- and 24- months after stent implantation

  6 to 24 month

Study Arms (2)

bare stent inserted

ACTIVE COMPARATOR

Standard bare stent will be placed

Device: Bare stent (Brand Cordis Type Palmaz Blue)

Covered stent inserted

EXPERIMENTAL

Covered stent will be placed

Device: Covered stent (Atrium Type V12)

Interventions

Covered stent (Atrium Type V12) DEVICE

An endovascular treatment that consists of inserting a covered stent into the stenosed vessels.

Covered stent inserted

Bare stent (Brand Cordis Type Palmaz Blue) DEVICE

An endovascular treatment that consists of inserting a stent into the stenosed vessels.

Also known as: Brand Cordis Type Palmaz Blue

bare stent inserted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with consensus diagnostic of CGI based on a clinical meeting with a gastroenterologist, a vascular surgeon and an interventional radiologist.
• Diagnostic consensus of CGI is based on.
• Presence of postprandial pain
• Unexplained weight loss (\>5% of normal body weight).
• Significant stenosis of \>50% of at least one of the gastrointestinal arteries on a recent CTA (Computer Tomographic Angiography) not older than one year, with maximum slice thickness 1 mm and enhancement in aorta of 300HU (Hounsfields Units)
• Mucosal ischemia detected by VLS (Visible Light Spectroscopy) or tonometry
• Patients over the age of 18 years.
• Patients who gave informed consent.
• Patients have sustained atherosclerosis.

You may not qualify if:

• Patients who don't give informed consent.
• Age \< 18 years
• No stenosis detected during arteriography.
• Renal insufficiency (GFR below 30 ml/min or GFR below 60 ml/min when comorbidities relevant to kidney function present).
• Previous stent placement in the to be treated gastrointestinal artery.
• Pregnancy
• Celiac artery compression syndrome.
• Vasculitis

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3015CE, Netherlands

Location

Related Publications (2)

• Terlouw LG, van Dijk LJD, van Noord D, Bakker OJ, Bijdevaate DC, Erler NS, Fioole B, Harki J, van den Heuvel DAF, Hinnen JW, Kolkman JJ, Nikkessen S, van Petersen AS, Smits HFM, Verhagen HJM, de Vries AC, de Vries JPM, Vroegindeweij D, Geelkerken RH, Bruno MJ, Moelker A; Dutch Mesenteric Ischemia Study Group. Covered versus bare-metal stenting of the mesenteric arteries in patients with chronic mesenteric ischaemia (CoBaGI): a multicentre, patient-blinded and investigator-blinded, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Apr;9(4):299-309. doi: 10.1016/S2468-1253(23)00402-8. Epub 2024 Jan 29.

  PMID: 38301673 DERIVED

• van Dijk LJD, Harki J, van Noord D, Verhagen HJM, Kolkman JJ, Geelkerken RH, Bruno MJ, Moelker A; Dutch Mesenteric Ischemia Study group (DMIS). Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial. Trials. 2019 Aug 20;20(1):519. doi: 10.1186/s13063-019-3609-8.

  PMID: 31429792 DERIVED

MeSH Terms

Conditions

Arteriosclerosis; Mental Disorders; Constriction, Pathologic; Necrosis; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Adriaan Moelker, dr

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating trialbureau

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 29, 2015
• Study Start: May 1, 2016
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

NL (1)