PREVENT: Promus BTK

NCT01500070 | Completed Phase 2 DMC

• 1 other identifier: FMRP-101020
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 8

Brief Summary

This is a single-arm, prospective, multi-center monitored trial recruiting patients with critical limb ischemia and with one or more lesions in the arteries below the knee. The immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific) will be evaluated. In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will be recruited. Primary endpoint is primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Claudication; Drug-Eluting Stent; BTK; Everolimus; CLI

Outcome Measures

Primary Outcomes (1)

• Primary patency

  Absence of restenosis (50% stenosis) or occlusion within the originally treated lesion based on angiography.

  12 months

Secondary Outcomes (9)

• Technical success

  1 day post-procedure

• Hemodynamic primary patency rate

  1, 6 and 12 month follow-up

• Limb-salvage

  1, 6 and 12 month follow-up

• Primary assisted patency rate

  1, 6 and 12 month follow-up

• Secondary patency rate

  1, 6 and 12 month follow-up

Study Arms (1)

Drug-eluting stent

EXPERIMENTAL

Patients implanted with the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).

Device: Everolimus-Eluting Stent (PROMUS ELEMENT)

Interventions

Everolimus-Eluting Stent (PROMUS ELEMENT) DEVICE

PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).

Drug-eluting stent

Eligibility Criteria

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

You may qualify if:

• Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is \>18 years old
• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient has a projected life-expectancy of at least 12 months
• The treating physician consider the patient eligible for below-the-knee treatment with the PROMUS ELEMENT Stent (Boston Scientific) and PROMUS ELEMENT PLUS Stent (Boston Scientific)
• Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
• Single or multiple lesions with minimally 70% stenosis in one or more infrapopliteal arteries, including the tibiofibular trunk
• A maximum of two focal target lesions in one or more infrapopliteal vessels
• Length of lesion is maximally 40 mm, allowing maximally 2 planned stents to be implanted
• Target vessel diameter visually estimated to be \>2.5mm and \<4.0mm
• Guidewire and delivery system successfully traversed lesion

You may not qualify if:

• Patient refusing treatment
• Previously implanted stent in the artery to be treated
• Failed PTA of target lesion/vessel less than 3 months prior to study procedure
• The reference segment diameter is not suitable for the available stent design
• Untreated flow-limiting inflow lesions
• Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
• Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
• Aneurysm in the target vessel
• Patient presents with renal failure, evidenced by a serum creatinine level \>2.0mg/dL
• Patient presents with platelet levels above or below normal range
• Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
• Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
• Septicemia or bacteremia
• Any previously known coagulation disorder, including hypercoagulability

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (8)

Imelda Hospital

Bonheiden, Antwerpen, 2820, Belgium

Location

OLV Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

AZ Sint-Blasius

Dendermonde, Oost-Vlaanderen, 9200, Belgium

Location

RZ Heilig Hart Tienen

Tienen, 3300, Belgium

Location

Herzzentrum Bad-Krözingen

Bad-Krözingen, Land Baden-Württemberg, 79189, Germany

Location

St. Fransiskus Hospital

Münster, North Rhine-Westphalia, 48145, Germany

Location

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

Location

Auckland City Hospital

Auckland, Auckland, 1023, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Bosiers, MD

  AZ Sint Blasius, Dendermonde, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 26, 2011
• Study Start: August 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

BE (4); DE (3); NZ (1)